Revised: 06-Jan-2009 07:36 AM
Viol Code Section Charge Statement
*** 402(a)(5), 801(a)(3); The food appears to be, in
ADULTERATION whole or in part, the product
of a diseased animal or of an
animal which has died
otherwise than be slaughter.
ADDED BULK 402(b)(4), 801(a)(3); The food appears to have a
ADULTERATION substance added to, mixed or
packed with it so as to
increase its bulk or weight,
or reduce its quality or
strength, or make it appear
better or of greater value
than it is.
AFLATOXIN 402(a)(1), 801(a)(3); The article appears to contain
ADULTERATION a mycotoxin, a poisonous and
deleterious substance which
may render it injurious to
health.
AGR RX 801(d)(1),(2); IMPORTATION The article appears to be a
RESTRICTED prescription drug manufactured
in the U.S. and offered for
import by other than the
manufacturer and reimportation
does not appear to have been
authorized by the Secretary
for use in a medical
emergency.
AGRINSULIN 801(d)(1),(2);IMPORTATION The article appears to be
RESTRICTED composed wholly or partly of
insulin manufactured in the US
and offered for import by
other than the manufacturer
and reimportation does not
appear to have been authorized
by the Secretary for a medical
emergency
ALCOHOL 402(d)(2), 801(a)(3); The article appears to be a
ADULTERATION confectionary that bears or
contains alcohol in excess of
1/2 of 1% by volume derived
solely from the use of
flavoring extracts.
ALLERGEN 403(w) 801(a)(3); Misbranding the label fails to declare all
major food allergens present
in the product, as required by
section 403(w)(1).
ANDRO 402(f)(1)(B),801(a)(3);ADULTER The article is subject to
ATION refusal of admission pursuant
to section 801(a)(3) in that
it appears to declare and/or
contain androstenedione, a new
dietary ingredient for which
there is inadequate
information to provide
reasonable assurance that such
ANTIBIOTIC 502(l), 801(a)(3); MISBRANDING The drug appears to purport,
or represented as, being
composed wholly or partly of
an antibiotic and it does not
appear to be from a batch with
respect to which a certificate
or release has been issued
pursuant to section 507.
REPEALED11/97
BACTERIA 402(a)(1), 801(a)(3); The article appears to contain
ADULTERATION a poisonous and deleterious
substance which may render it
injurious to health. Contains
BANNED 501(g), 801(a)(3); The article appears to be a
ADULTERATION banned device.
BIO TOXIN 402(a)(1), 801(a)(3), The article is subject to
Adulteration refusal of admission pursuant
to Section 801(a)(3) in that
it appears to contain a
poisonous and deleterious
substance which would
ordinarily render it injurious
to health. Appears to contain
BIO TOXIN 801
BSE DRUGS 501(a)(2)(A), 801(a)(1); The article is subject to
Adulteration refusal of admission pursuant
to Section 801(a)(1) in that
it appears to have been
prepared, packed or held under
insanitary conditions whereby
it may have been rendered
injurious to health.
BSE FILTH 402(a)(3), 801(a)(3); The article is subject to
Adulteration refusal of admission pursuant
to Section 801(a)(3) in that
it appears to be unfit for
food.
BUTTER 402(e), 801(a)(3); The article appears to be
ADULTERATION oleo/margarine or butter with
raw materials consisting in
whole or in part of a filthy,
putrid, or decomposed
substance or the article is
otherwise be unfit for food.
CALIBRATED 502(f)(1); 801(a)(3), The article is subject to
misbranding refusal in that it is
calibrated in units not
commonly used in the United
States
CHLORAMP 402(a)(2)(C)(i), 801(a)(3); The article appears to contain
ADULTERATION a food additive, namely
chloramphenicol, that is
unsafe within the meaning of
21 U.S.C. 348.
COL ADDED 501(a)(4)(A), 801(a)(3); The article appears to bear or
ADULTERATION contain, for the purpose of
coloring only, a color
additive which is unsafe
within the meaning of Section
721(a).
COLOR 601%
COLOR LBLG 602(e), 801(a)(3); MISBRANDING The color additive appears to
not have its packaging and
labeling in conformity with
such requirements as issued
under section 721.
COLOR LBLG 403(k), 801(a)(3); MISBRANDING The article appears to contain
an artificial coloring and it
fails to bear labeling stating
that fact.
CONCEALED 402(b)(3), 801(a)(3); It appears to be food which
ADULTERATION has damage or inferiority
concealed in any manner.
CONTAINER 501(a)(3), 801(a)(3); The container appears to be
ADULTERATION composed, in whole or in part,
of a poisonous or deleterious
substance which may render the
contents injurious to health.
CONTAINER 601(d), 801(a)(3); The container appears to be
ADULTERATION composed, in whole or in part,
of a poisonous or deleterious
substance which may render the
contents injurious to health.
CONTAINER 402(a)(6), 801(a)(3); The container appears to be
ADULTERATION composed, in whole or in part,
of a poisonous or deleterious
substance which may render
the contents injurious to
health.
CONTAM CAN 402(a)(1), 801(a)(3); The article appears to be held
ADULTERATION in a container containing a
poisonous or deleterious
substance which may render it
injurious to health.
COSM COLOR 601(e), 801(a)(3); The cosmetic appears to not be
ADULTERATION a hair dye, and is, bears, or
contains a color additive
which is unsafe within the
meaning of section 721(a).
COSM MISB 602(a) & 801(a)(3); The cosmetic's labeling
MISBRANDING appears to be false or
misleading within the meaning
of Section 201(n).
COSM MISB2 602(a) & 801(a)(3); The article is subject to
MISBRANDING refusal of admission pursuant
to Section 801(a)(3) in that
it appears that its labeling
is false or misleading in any
particular [Misbranding,
Section 602(a)].
COSMETIC 601(c), 801(a)(3); The article appears to be an
Adulteration ingredient in a cosmetic
product and may have been
prepared packed or held under
insanitary conditions whereby
it may have become
contaminated with filth or
rendered injurious to health.
COSMETLBLG 5(c)(3)(B); 801(a)(3) It appears that the cosmetic
Misbranding consists of two or more
ingredients and the label does
not list the common or usual
name of each ingredient.
COSMETLBLG 5(c)(3)(A); 801(a)(3) It appears the label does not
Misbranding bear the common or usual name
of the cosmetic.
COUMARIN 402(a)(1), 801(a)(3), The article appears to bear or
Adulteration contain Coumarin, a poisonous
or deleterious substance,
which may render it injurious
to health.
CSTIC LBLG 602(a) and/or (b), and/or (c), The labeling appears to fail
801(a)(3); MISBRANDING to comply with cosmetic
labeling requirements of
Section 602(a), and/or (b),
and/or (c), and as identified
by 21 C.F.R. Part 701.
CYCLAMATE 402(a)(2)(C); 801(a)(3) The article appears to bear or
contain cyclamate, an unsafe
food additive within the
meaning of Section 409
DANGEROUS 502(j), 801(a)(3); MISBRANDING The article appears to be
dangerous to health when used
in the dosage or manner, or
with the frequency or
duration, prescribed,
recommended, or suggested in
the labeling thereof.
DE IMP GMP 801(a)(1); NON CONFORMING The methods used in, or the
MANUFACTURING PRACTICES facilities or controls used
for the manufacture, packing,
storage or installation do not
conform to the requirements
under section 520(f).
DE/RX KIT 801(d)(1),(2); IMPORTATION The article appears to be a
RESTRICTED combination medical
device/prescription drug kit
for which the prescription
drug component was
manufactured in the U.S., is
offered for import by other
than the manufacturer, and
reimportation does not appear
DEVICE GMP 501(h), 801(a)(3); The methods, facilities, or
ADULTERATION controls used for the
article's manufacture,
packing, storage. or
installation do not conform
with applicable requirements
under section 520(f)(1) or a
condition prescribed by an
order under section 520(f)(2).
DEVICEGMPS 501(h), 801(a)(1); The methods, facilities, or
ADULTERATION controls used for the
article's manufacture,
packing, storage, or
installation do not conform
with applicable requirements
under section 520(f)(1) or a
condition prescribed by an
order under section 520(f)(2).
DEVNOEXPT 501(i), 801(a)(3)
DIET INGRE 402(a)(3), 801(a)(3); The article is subject to
Adulteration refusal of admission pursuant
to Section 801(a)(3) in that
it appears to be for use as an
ingredient in a dietary
supplement and appears to be
or may be otherwise unfit for
food.
DIETARY 403(j), 801(a)(3); MISBRANDING The article purports to be or
is represented for special
dietary uses and its label
does not appear to bear the
nutritional information
required by regulation.
DIETARYLBL 403(s)(2)(B), 801(a)(3), The label/labeling of the
misbranded dietary supplement fails to
identify the product by using
the term "dietary supplement".
DIOXIN 402(a)(1),402(a)(2)(A),402(a)( The article appears to bear or
2)(C)(i),801(a)(3)-Adulterated contain dioxins and/or PCB
compounds, poisonous or
deleterious substances and/or
unapproved food additives
which may render it injurious
to health.
DIRECTIONS 502(f)(1), 801(a)(3); The article appears to lack
MISBRANDING adequate directions for use.
DIRSEXMPT 502(f)(1), 801(a)(3); The article appears to lack
MISBRANDING adequate directions for use,
and the article does not
appear to be exempt from such
requirements.
DISEASED 402(a)(5), 801(a)(3); The food appears to be, in
ADULTERATION whole or in part, the product
of a diseased animal or of an
animal which has died
otherwise than by slaughter.
DR QUALITC 501(c), 801(a)(3); The drug appears to be
ADULTERATION represented as not being
recognized in an official
compendium and appears its
strength differs from or its
quality or purity falls below,
that which it purports or is
represented to possess.
DR QUALITY 501(b), 801(a)(3); The article appears to be
ADULTERATION represented as a drug the name
of which is recognized in an
official compendium and its
strength appears to differ
from or its quality or purity
appear to fall below the
standards set forth in such
compendium.
DR QUALITY 501b
DRUG COLOR 502(m), 801(a)(3); MISBRANDING The article appears to be a
color additive the intended
use of which is for the
purpose of coloring only, and
its packaging and labeling do
not conform to regulations
issued under section 721.
DRUG GMPS 501(a)(2)(B), 801(a)(3); It appears that the methods
ADULTERATION used in or the facilities or
controls used for manufacture,
processing, packing, or
holding do not conform to or
are not operated or
administered in conformity
with current good
manufacturing practices.
DRUG NAME 502(e)(1); 801(a)(3); The article appears to be a
Misbranding drug and fails to bear the
proprietary or established
name and/or name and quantity
of each active ingredient.
DULCIN 402(a)(2)(C); 801(a)(3) The article appears to bear or
contain dulcin, an unsafe food
additive within the meaning of
Section 409
DV NAME 502(e)(2); 801(a)(3); The article appears to be a
Misbranding device and its labeling fails
to bear the proprietary or
established name.
DV QUALITY 501(c); 801(a)(3) Adulteration The article appears to be a
device whose quality falls
below that which it purports
or is represented to possess.
EPHEDALK 801(a)3), 402(f)(1); The product is subject to
ADULTERATION refusal of admission pursuant
to Section 801(a)(3) in that
it is a dietary supplement or
a dietary ingredient that
appears to contain ephedrine
alkaloids, which presents an
unreasonable risk of illness
or injury under the conditions
EXCESS SUL 402(a)(1), 801(a)(3); The article appears to contain
ADULTERATION excessive sulfites, a
poisonous and deleterious
substance which may render it
injurious to health.
EXPIRED 501(c); 801(a)(3) Adulteration the product strength differs
from, or its purity or quality
falls below, that which it
purports or is represented to
possess in that it is past its
labeled expiration date.
FAILS STD 501(e), 801(a)(3); The article appears to be a
ADULTERATION device which is subject to a
performance standard
established under Section 514
and does not appear to be in
all respects in conformity
with such standard.
FALSE 403(a)(1), 801(a)(3); the labeling appears to be
MISBRANDING false and misleading in any
particular.
FALSE 502(a), 801(a)(3); MISBRANDING The labeling for this article
appears to be false or
misleading in that it fails to
reveal a material fact
FALSECAT 403(t), 801(a)(3) The article is subject to
refusal of admission pursuant
to section 801(a)(3) in that
it appears to be misbranded
because it purports to be or
is represented as catfish but
is not a fish classified
within the family Ictaluridae.
FEED & NAD 501(a)(6), 801(a)(3); The article appears to be an
ADULTERATION animal feed bearing or
containing a new animal drug,
and such animal feed is unsafe
within the meaning of section
512.
FILTH 601(b), 801(a)(3); The cosmetic appears to
ADULTERATION consist in whole or in part of
any filthy, putrid, or
decomposed substance.
FILTHY 402(a)(3), 801(a)(3); The article appears to consist
ADULTERATION in whole or in part of a
filthy, putrid, or decomposed
substance or be otherwise
unfit for food.
FLAVR LBLG 403(k), 801(a)(3); MISBRANDING The article appears to contain
an artificial flavoring and it
fails to bear labeling stating
that fact.
FLUOROCARB 501(a)(5), 801(a)(3); The article appears to be a
ADULTERATION new animal drug containing
chloroflurocarbons in
violation of 21 CFR 2.125.
FLUOROCARB 402(a)(2)(A), 801(a)(3); The article appears to contain
ADULTERATION chloroflurocarbons in
violation of 21 CFR 2.125.
FLUOROCARB 601(a), 801(a)(3); The article appears to contain
ADULTERATION chloroflurocarbons in
violation of 21 CFR Part
2.125.
FORBIDDEN 801(a)(2); FORBIDDEN OR The article appears to be
RESTRICTED IN SALE forbidden or restricted in
sale in the country in which
it was produced or from which
it was exported.
FOREIGN OB 402(a)(3), 801(a)(3); The article appears to consist
ADULTERATION in whole or in part of a
filthy, putrid, or decomposed
substance, or is otherwise
unfit for food in that it
appears to contain foreign
objects.
FRNMFGREG 502(o), 801(a)(3); MISBRANDING The foreign manufacturer has
not registered as required by
section 510(i)(1)
GINSENG 402(a)(2)(C), 801(a)(3); The article appears to bear or
ADULTERATION contain "Ginseng", a food
additive which is unsafe
within the meaning of Section
409.
HEALTH C 801(a)(3); 403(r)(1)(A)/(B) The article appears to be
misbranding misbranded in that the label
or labeling bears an
unauthorized nutrient
content/health claim.
HELD INSAN 601(c), 801(a)(3); The cosmetic appears to have
ADULTERATION been prepared, packed, or held
under insanitary conditions
whereby it may have become
contaminated with filth, or
whereby it may have been
rendered injurious to health.
HEPATITISA Section 801(a)(3), 402(a)(1); The article appears to contain
ADULTERATION Hepatitis A Virus, a poisonous
or deleterious substance which
may render it injurious to
health.
HISTAMINE 402(a)(1), 801(a)(3); The article appears to bear or
Adulteration contain histamine, a poisonous
and deleterious substance in
such quantity as ordinarily
renders it injurious to
health.
HOLES 501(c); 801(a)(3) Adulteration The quality of the article
falls below that which it
purports or is represented to
possess, in that the devices
contain defects/holes.
IMBED OBJT 402(d)(1), 801(a)(3); The article appears to be a
ADULTERATION confectionary that has
partially or completely
imbedded therein any
nonnutritive object.
IMITATION 403(c), 801(a)(3); MISBRANDING The article appears to be an
imitation of another food, and
the label does not bear in
type of uniform size and
prominence, the word
"imitation" and immediately
thereafter, the name of the
food imitated.
IMPTRHACCP 801(a)(3) , 402(a)(4) The food appears to have been
Adulteration prepared, packed or held under
insanitary conditions, or may
have become injurious to
health, due to the failure of
the importer to provide
verification of compliance
pursuant to 21 CFR 123.12(d).
INCONSPICU 502(c), 801(a)(3); MISBRANDING Information required by the
Act to be on the label or
labeling does not appear to be
conspicuous enough as to
render it likely to be read
and understood by the ordinary
individual under customary
conditions of purchase and
use.
INCONSPICU 403(f), 801(a)(3); MISBRANDING Information required by the
Act to be on the label or
labeling does not appear to be
conspicuous enough as to
render it likely to be read
and understood by the ordinary
individual under customary
conditions of purchase and
use.
INGRED FIL 402(a)(4), 801(a)(3); The article appears to be an
Adulteration ingredient in a dietary
supplement and may have been
prepared packed or held under
insanitary conditions whereby
it may have become
contaminated with filth or
rendered injurious to health.
INSAN BSE 402(a)(4), 801(a)(3); The article is subject to
Adulteration refusal of admission pursuant
to Section 801(a)(3) in that
it appears to have been
prepared, packed or held under
insanitary conditions whereby
it may have been rendered
injurious to health.
INSANITARY 501(a)(2)(A), 801(a)(3); The article appears to have
ADULTERATION been prepared, packed or held
under insanitary conditions
whereby it may have been
contaminated with filth, or
whereby it may have been
rendered injurious to health.
INSANITARY 402(a)(4), 801(a)(3); The article appears to have
ADULTERATION been prepared, packed, or held
under insanitary conditions
whereby it may have become
contaminated with filth, or
whereby it may have been
rendered injurious to health.
INSULIN 502(k), 801(a)(3); MISBRANDING The drug appears to purport,
or represented as, being
composed wholly or partly of
insulin and it does not appear
to be from a batch with
respect to which a certificate
or release has been issued
pursuant to section
506.REPEALED 11/97
INVDEVICE 501(i), 801(a)(3); The article is subject to
ADULTERATION refusal of admission pursuant
to Section 801(a)(3) in that
it appears to be a device for
investigational use for which
no exemption has been granted
as prescribed by Section
520(g)
JUICE % 403(i)(2), 801(a)(3); It appears the food is a
MISBRANDING beverage containing vegetable
or fruit juice and does not
bear a statement on the label
in appropriate prominence on
the information panel of the
total percentage of such fruit
or vegetable juice contained
therein.
LABELING Section 4(a); 801(a)(3) The article appears in
Misbranding violation of FPLA because of
its placement, form and/or
contents statement.
LACK NOTIF 301(s) Adulterated, 801(a)(3), lack
of documentation establishing
that the infant formula meets
all notification conditions
required by 412(c) or 412(d),
Prohibited Act, Section
301(s).
LACKS FIRM 403(e)(1), 801(a)(3); The food is in package form
MISBRANDING and appears to not bear a
label containing the name and
place of business of the
manufacturer, packer, or
distributor.
LACKS FIRM 502(b)(1), 801(a)(3); The article is in package form
MISBRANDING and appears to not bear a
label containing the name and
place of business of the
manufacturer, packer, or
distributor.
LACKS N/C 403(e)(2), 801(a)(3); The food is in package form
MISBRANDING and appears to not have a
label containing an accurate
statement of the quantity of
the contents in terms of
weight, measure or numerical
count and no variations or
exemptions have been
prescribed by regulations.
LACKS N/C 502(b)(2), 801(a)(3); The article is in package form
MISBRANDING and appears to not have a
label containing an accurate
statement of the quantity of
the contents in terms of
weight, measure or numerical
count and no variations or
exemptions have been
prescribed by regs.
LBL STEEL 502(a); 801(a)(3); Misbranding The labeling for this article
appears to be false or
misleading: labeling suggests
it is composed of stainless
steel, but it doesn't meet
standard requirements for the
appropriate type of stainless
steel.
LBLG ADVER 502(a), 201(n) and 801(a)(3) The art apprs misbranded
Misbranding because its lblg is misledg
namely it fails to reveal
facts (non-sterility) that are
material w/respect to
consequences frm the use of
the art accordg to lblg or
advertisg or undercondtns of
customary or usual use
LEAK/SWELL 402(a)(3), 801(a)(3); The article appears to be held
ADULTERATION in swollen containers or
contains micro leaks.
LENS CERT 502(a), 801(a)(3); MISBRANDING The lenses are declared by
accompanying certificate to
meet the requirements for
impact-resistant lenses in 21
CFR 801.410 but does not
appear to be impact-resistant.
LIST INGRE 403(i)(2), 801(a)(3); It appears the food is
MISBRANDING fabricated from two or more
ingredients and the label does
not list the common or usual
name of each ingredient.
LISTERIA 402(a)(1), 801(a)(3); The article appears to contain
ADULTERATION Listeria, a poisonous and
deleterious substance which
may render it injurious to
health.
MELAMINE 402(a)(2)(C)(i), 801(a)(3); The article is subject to
ADULTERATION refusal of admission in that
it appears to bear or contain
a food additive, namely
melamine and/or a melamine
analog, that is unsafe within
the meaning of section 409.
MELAMINE 402(a)(1), 801(a)(3), The article is subject to
Adulteration refusal of admission pursuant
to Section 801(a)(3) in that
it appears to bear or contain
a food additive, namely
melamine and/or a melamine
analog, that is unsafe within
the meaning of Section 409
[Adulteration, Section
MELAMINE 402(a)(2)(C)(i), 801(a)(3); The article is subject to
ADULTERATION refusal of admission pursuant
to Section 801(a)(3) in that
it appears to bear or contain
a food additive, namely
melamine and/or a melamine
analog, that is unsafe within
the meaning of section 409
[Adulteration, section
MFR INSAN 801(a)(1); INSANITARY The article appears to have
MANUFACTURING, PROCESSING OR been manufactured, processed,
PACKING or packed under insanitary
conditions.
MFRHACCP 402(a)(4), 801(a)(3) The product appears to have
been prepared, packed, or held
under insanitary conditions,
or it may be injurious to
health, due to failure of the
foreign processor to comply
with 21 CFR 123.
N-RX INACT 502(e)(1); 801(a)(3); The article appears to be a
Misbranding nonprescription drug and fails
to bear the established name
of each inactive ingredient in
alphabetical order on the
outside container of the
retail package.
NEEDS ACID 402(a)(4), 801(a)(3); The food appears to have been
ADULTERATION prepared, packed, or held
under insanitary conditions,
or it may have been rendered
injurious to health due to
inadequate acidification.
NEEDS FCE 402(a)(4), 801(a)(3); It appears the manufacturer is
ADULTERATION not registered as a low acid
canned food or acidified food
manufacturer pursuant to 21
CFR 108.25(c)(1) or
108.35(c)(1).
NEW VET DR 501(a)(5), 801(a)(3); The article appears to be a
ADULTERATION new animal drug which is
unsafe within the meaning of
Section 512(a) in that there
is not in effect an approval
of an applications filed with
respect to its intended use or
uses.
NITROFURAN 402(a)(2)(C)(i), 801(a)(3); The article is subject to
Adulteration refusal of admission in that
it appears to bear or contain
a food additive, namely
nitrofurans, that is unsafe.
NO 510(K) 801(a)(3); 502(o) Misbranding It appears that a notice or
other information respecting
the device was not provided to
FDA, as required by Section
510(k) and the device was not
found to be substantially
equivalent to a predicate
device.
NO ENGLISH 502(c); 801(a)(3);Misbranding Required label or labeling
appears to not be in English
in violation of 21 C.F.R.
801.15(c)(1)
NO ENGLISH 403(f), 801(a)(3); MISBRANDING Required label or labeling
appears to not be in English
per 21 CFR 101.15(c).
NO ENGLISH 502(c); 801(a)(3) ;MISBRANDING Required label or labeling
appears to not be in English
in violation of 21 C.F.R.
201.15(c)(1).
NO LICENSE 502(f)(1), 801(a)(3); The article appears to be a
MISBRANDING & PHS BIOL. ACT biological product not
351 manufactured at an
establishment holding an
unsuspended and unrevoked
license issued under the
Public Health Service Act,
Biological Products section
351.
NO PERMIT 1, 2; PROHIBITION WITHOUT The article of milk or cream
PERMIT is not accompanied by a valid
import milk permit, as
required by the Federal Import
Milk Act (21 U.S.C. 141-149).
NO PMA 501(f)(1)(B), 801(a)(3); The article appears to be a
ADULTERATION class III device without an
approved application for
premarket approval pursuant to
section 515(a).
NO PMA/PDP 501(f)(1)(A); 801(a)(3); The article appears to be a
ADULTERATION class III dev.w/o an approved
applic. for premarket
approval, and/or a notice of
completion of product
development protocol filed per
sect.515(b) or exempt per
sect.520(g)(1). [Adulteration,
Section 501(f)(1)(A)]
NO PROCESS 402(a)(4), 801(a)(3); It appears that the
ADULTERATION manufacturer has not filed
information on its scheduled
process as required by 21 CFR
108.25(c)(2) or 108.35(c)(2).
NO REGISTR 536(a); Failure to file The article appears to be an
initial report electronic product that does
not comply with an applicable
standard as prescribed by
Section 534 because no
reporting has been provided as
required by Section 537(b).
NO TAG 536(a),(b); NOT CERTIFIED It appears that the article
does not have affixed to it a
certification in the form of a
label or tag in conformity
with section 534(h).
NOCONTCODE 402(a)(4), 801(a)(3); The low acid or acidified food
ADULTERATION appears to have been prepared,
packed, or held under
insanitary conditions, or it
may be injurious to health,
due to failure to mark with a
permanent container code
pursuant to 21 CFR 113.60(c)
or 114.80(b).
NON STD 536(a),(b); NON STANDARD It appears that the article
fails to comply with
applicable standards
prescribed under section 534.
NONNUT SUB 402(d)(3), 801(a)(3); The article appears to be
ADULTERATION confectionery and it bears or
contains a nonnutritive
substance.
NONRSP-PRC 402(a)(4), 801(a)(3); The article appears to have
ADULTERATION been prepared or packed under
insanitary conditions whereby
it may have been rendered
injurious to health due to
inadequate processing in that
the scheduled process filed by
the manufacturer pursuant to
21 CFR 108.35(c)(2) appears to
NONRSP-VER 402(a)(4), 801(a)(3); The article appears to have
ADULTERATION been prepared or packed under
insanitary conditions whereby
it may have been rendered
injurious to health due to
inadequate processing in that
the scheduled process filed by
the manufacturer pursuant to
21 CFR 108.35 (c)(2) appears
NONSTEEL 502(a) and/or 502(f)(1); Labeling appears false or
Misbranding misleading or fails to bear
adequate directions for
use,because the article
appears to be misrepresented
as a disposable single use
instrument when it is intended
for use as a stainless steel
multi-use instrument.
NOT IMPACT 501(c), 801(a)(3); The article appears to not
ADULTERATION have impact-resistant lenses
in accordance with 21 CFR
801.410.
NOT LISTED 502(o), 801(a)(3); MISBRANDING It appears the drug or device
is not included in a list
required by Section 510(j), or
a notice or other information
respecting it was not provided
as required by section 510(j)
or 510(k).
NUTR DEF 412(a)(1), 801(a)(3); the infant formula appears to
Adulterated adulterated in that it does
not provide the nutrients
required by 21 CFR 107.100
NUTR UNIT 403(f), 801(a)(3); MISBRANDED The article is subject to
refusal of admission pursuant
to Section 801(a)(3) in that
the infant formula appears to
be misbranded within the
meaning of Section 403 in that
the labeling fails to use the
proper units to declare the
nutrients as specified in 21
NUTRIT LBL 403(q); 801(a)(3); Misbranding The article appears to be
misbranded in that the label
or labeling fails to bear the
required nutrition
information.
OFF ODOR 402(a)(3), 801(a)(3); The article appears to consist
ADULTERATION in whole or in part of a
filthy, putrid, or decomposed
substance or be otherwise
unfit for food. Contains an
off odor.
OMITTED 402(b)(1), 801(a)(3); It appears that a valuable
ADULTERATION constituent of the article has
been in whole or in part
omitted or abstraced from the
article.
OPTION ING 403(g)(2), 801(a)(3); It appears to be a food for
MISBRANDING which a definition and
standard of identity have been
prescribed by regulations
under section 401 and appears
to not be labelled with the
common names of the optional
ingredients specified therein.
PATULIN 402(a)(1), 801(a)(3); The article appears to contain
ADULTERATION patulin, a poisonous and
deleterious substance which
may render it injurious to
health.
PB-FOOD 402(a)(1); 801(a)(3); The article is subject to
Adulteration refusal of admission pursuant
to Section 801(a)(3) in that
it appears to contain a
poisonous or deleterious
substance, lead, which may
render it injurious to health.
PERSONALRX 502(a) & (f)(1), 801(a)(3); The article appears to be a
MISBRANDING drug which requires a
prescription from your doctor.
PESTICIDE 402(a)(2)(B), 801(a)(3); The article appears to be a
ADULTERATION raw agricultural commodity
that bears or contains a
pesticide chemical which is
unsafe within the meaning of
Section 408(a).
PESTICIDES 402(a)(2)(B), 802(a)(B); The article is subject to
ADULTERATION refusal of admission pursuant
to section 801(a)(3) in that
it appears to be adulterated
because it contains a
pesticide chemical, which is
in violation of section
402(a)(2)(B). Contains:
POIS CHLOR 402(a)(1), 801(a)(3); The article appears to contain
ADULTERATION a poisonous or deleterious
substance, namely
chloramphenicol, which may
render it injurious to health.
POISON PKG 502(p), 801(a)(3); MISBRANDING The article appears to be a
drug and its packaging and
labeling is in violation of
an applicable regulation
issued pursuant to section 3
or 4 of the Poison Prevention
Packaging Act of 1970.
POISONOUS 402(a)(1), 801(a)(3); The article appears to contain
ADULTERATION a poisonous or deleterious
substance which may render it
injurious to health.
POISONOUS 601(a), 801(a)(3); The cosmetic appears to bear
ADULTERATION or contain a poisonous or
deleterious substance which
may render it injurious to
users under the conditions
prescribed in the labeling
thereof, or, under such
conditions of use as are
customary or usual.
POSS N/STR 501(a)(1); 801(a)(3) The article appears to consist
ADULTERATION in whole or in part of any
filthy, putrid, or decomposed
substance, namely, potentially
infectious organisms
PRESRV LBL 403(k), 801(a)(3); MISBRANDING The article appears to contain
a chemical preservative and it
fails to bear labeling stating
that fact including its
function.
RADIONUC 402(a)(1); 801(a)(3); Article appears to contain the
Adulteration radionuclide, Cesium-137, a
poisonous and deleterious
substance which may render it
injurious to health.
RECORDS 502(t), 801(a)(3); MISBRANDING The article appears to be a
device and the requirements
under 518 or to furnish any
material or information
required by or under section
519 respecting a device were
not met.
REDUCED 501(d)(1), 801(a)(3); It appears to be a drug that a
ADULTERATION substance has been mixed or
packed with so as to reduce
its strength.
REGISTERED 502(o), 801(a)(3); MISBRANDING It appears the device is
subject to listing under
510(j) and the initial
distributor has not registered
as required by 21 CFR 807.20
(a)(4).
REJECT TEA 1 (21USC41); PROHIBITED TEA The article is inferior in
purity, quality, and fitness
for consumption to the
standards provided in section
43.TEA ACT REPEALED!
RX DEVICE 502(a),(f)(1), 801(a)(3); The article appears to be a
MISBRANDING prescription device without a
prescription device legend as
required by 21 CFR 801.109.
RX LEGEND 502(a) & (f)(1), 801(a)(3); The article appears to be a
MISBRANDING prescription drug without a
prescription drug legend as
required by Section 503(b)(4).
RXCOMPOUND 503(b)(4)(A) & 502(c), the labeling fails to bear, at
801(a)(3); MISBRANDING a minimum, the symbol "Rx
only."
RXPERSONAL 502(a), 502(f)(1), 801(a)(3), The article appears to be a
MISBRANDING device which requires a
prescription from your doctor.
SACCHARIN 403(o); 801(a)(3) Misbranded The article contains
Saccharin, a non-nutritive
sweetner, and its label or
labeling fails to bear the
required warning statement.
SACCHARLBL 403(i); 803(a)(3) Misbranding The article contains
Saccharin, a non-nutritive
sweetener, and its label or
labeling fails to list it as
an added ingredient
SALMONELLA 402(a)(1), 801(a)(3); The article appears to contain
ADULTERATION Salmonella, a poisonous and
deleterious substance which
may render it injurious to
health.
SBGINSENG 801(a)(3); 403(u) Misbranding The article is subject to
refusal of admission in that
it appears to be Misbranded
because it or its ingredients
purport to be or are
represented as Ginseng, but
are not an herb or herbal
ingredient derived from a
plant classified within the
SHIGELLA 402(a)(1), 801(a)(3); The article appears to contain
ADULTERATION Shigella, a poisonous and
deleterious substance which
may render it injurious to
health.
SOAKED/WET 402(a)(4), 801(a)(3); The article appears to have
ADULTERATION been prepared, packed, or held
under insanitary conditions
whereby it may have become
contaminated with filth, or
whereby it may have been
rendered injurious to health
in that it appears to been
held in water.
STAINSTEEL 501(c); 801(a)(3) Adulteration The article appears to be a
device whose quality falls
below that which it purports
or is represented to possess,
in that instrument is
represented as stainless steel
but does not meet requirements
for such steel for surgical
instruments.
STARANISE 402(a)(2)(C)(i), 801(a)(3), The article appears to bear or
Adulteration contain a food additive,
Japanese star anise, that is
unsafe within the meaning of
section 409.
STD FILL 403(h)(2), 801(a)(3); The article appears to be
MISBRANDING represented as a food for
which a standard of fill of
container has been prescribed
by regulations as provided by
section 401 and it appears it
falls below the standard of
fill and its label does not so
indicate.
STD IDENT 403(g)(1), 801(a)(3); The food appears to be
MISBRANDING represented as a food for
which a definition and
standard of identity have been
prescribed by regulations as
provided by section 401 and
the food does not appear to
conform to such definition and
standard.
STD LABEL 502(s), 801(a)(3); MISBRANDING The article appears to not
bear labeling prescribed by
the performance standard
established under section 514.
STD NAME 403(g)(2), 801(a)(3); It appears to be a food for
MISBRANDING which a definition and
standard of identity have been
prescribed by regulations
under section 401 and appears
to not be labelled with the
name specified in the
definition and standard.
STD QUALIT 403(h)(1), 801(a)(3); The article appears to be
MISBRANDING represented as a food for
which a standard of quality
has been prescribed by
regulation as provided by Sec.
401 and it appears its quality
falls below such standard and
its label does not so
indicate.
STERILITY 501(a)(2)(A), 801(a)(3); The article appears to have
ADULTERATION been prepared, packed or held
under insanitary conditions
whereby it may have been
contaminated with filth, or
whereby it may have been
rendered injurious to health.
STERILITY 501(a)(1), 801(a)(3); The article appears to consist
ADULTERATION in whole or in part of any
filthy, putrid, or decomposed
substance.
SUBSTITUTE 402(b)(2), 801(a)(3); It appears that a substance
ADULTERATION has been substituted wholly or
in part for one or more of the
article's ingredients.
SUBSTITUTE 501(d)(2), 801(a)(3); It appears to be a drug that a
ADULTERATION substance has been substituted
wholly or in part.
SULFITELBL 403(a)(1), 801(a)(3) The article is subject to
;MISBRANDING refusal of admission pursuant
to section 801(a)(3) in that
it appears to be misbranded
because 1) it appears to
contain sulfites but the label
fails to declare the presence
of sulfites, a fact material
to sulfite-sensitive
TAMPERING 501(a)(2)(B), 801(a)(3); It appears that the packing
ADULTERATION does not conform with current
good manufacturing practices
under 21 CFR 211.132 for
tamper-resistant packaging.
TISSUE 361 This human cell, tissue, and
cellular and tissue-based
product is in violation of
Section 361 of the Public
Health Service Act.
TRANSFAT 403(q), 801(a)(3) ;MISBRANDING The product is misbranded
under Section 403(q) because
the nutrition label does not
provide all of the information
required by 21 CFR 101.9(c);
specifically, the label does
not bear the amount of trans
fat [21 CFR 101.9(c)(2)(ii)].
UNAPPROVED 505(a), 801(a)(3); UNAPPROVED The article appears to be a
NEW DRUG new drug without an approved
new drug application.
UNDER PRC 402(a)(4), 801(a)(3); The article appears to have
ADULTERATION inadequate processing in
having been prepared, packed,
or held under insanitary
conditions whereby it may have
been rendered injurious to
health.
UNFIT4FOOD 402(a)(3), 801(a)(3); The article is subject to
ADULTERATION refusal of admission pursuant
to section 801(a)(3) in that
it appears to be unfit for
food [Adulteration, 402(a)(3)]
UNSAFE ADD 402(a)(2)(C)(i), 801(a)(3); The article appears to bear or
ADULTERATION contain a food additive which
is unsafe within the meaning
of Section 409. Contains
UNSAFE COL 501(a)(4)(B), 801(a)(3); The article appears to be a
ADULTERATION color additive for the
purposes of coloring only in
or on drugs or devices, and is
unsafe within the meaning of
Section 721(a).
UNSAFE COL 402(c), 801(a)(3); The article appears to be, or
ADULTERATION to bear or contain a color
additive which is unsafe
within the meaning of Section
721(a).
UNSAFE SUB 402(a)(2)(A), 801(a)(3); The article appears to bear or
ADULTERATION contain a substance which is
unsafe within the meaning of
Section 406.
UNSFDIETLB 402(f)(1)(A), 801(a)(3) The article appears to be a
Adulteration dietary supplement or contain
a dietary ingredient that
presents a significant or
unreasonable risk of illness
or injury under the conditions
of use set out in the labeling
or, if none are set out in the
labeling, under customary
UNSFDIETSP 402(f)(1)(B), 801(a)(3) The article appears to be a
Adulteration dietary supplement or
ingredient for which there is
inadequate information to
provide reasonable assurance
that such ingredient does not
present a significant or
unreasonable risk of illness
or injury.
UNSFDIETUS 402(f)(1)(D), 801(a)(3) The article is or contains a
Adulteration dietary supplement that
renders it adulterated under
paragraph (a)(1) under
conditions of use recommended
or suggested in the labeling
of such dietary supplement.
USUAL NAME 403(i)(1), 801(a)(3); It appears that the label does
MISBRANDING not bear the common or usual
name of the food.
VET LEGEND 502(a) & (f)(1), 801(a)(3); The article appears to be a
MISBRANDING veterinary drug without the
"Caution" statement as
required by Section 503(f)(4).
VETDRUGRES 402(a)(2)(C)(ii); 801(a)(3); The article appears to contain
ADULTERATION a new animal drug (or
conversion product thereof)
that is unsafe within the
meaning of section 512.
Product contains
VITAMN LBL 403(a)(2), 801(a)(3); The food appears to be subject
MISBRANDING to section 411 and its
advertising is false or
misleading in a material
respect or its labeling is in
violation of section
411(b)(2).
WARNINGS 502(f)(2), 801(a)(3); It appears to lack adequate
MISBRANDING warning against use in a
pathological condition or by
children where it may be
dangerous to health or against
an unsafe dose, method,
administering duration,
application, in manner/form,
to protect users.
WRONG IDEN 403(b), 801(a)(3); MISBRANDING The article appears to be
offered for sale under the
name of another food.
YELLOW #5 402(c), 403(m), 801(a)(3); The food appears to bear or
ADULTERATION, MISBRANDING contain the color additive FD
& C Yellow No. 5, which is not
declared on the label per 21
CFR 74.705 under section 721.