Note: Although this FDA-483 is an
accurate representation of the original FDA-483 issued to the firm, it is not an exact
copy. Slight modifications to the original FDA-483 have been made to accommodate its
conversion to the HTML format. A scanned copy of the original FDA-483 is available in PDF format on this website. |
DEPARTMENT
OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION |
DISTRICT
OFFICE ADDRESS AND PHONE NUMBER
60 Eighth Street
Atlanta, GA 30309
404-253-1163 |
DATE(S)
OF INSPECTION
12/21/2005 - 01/19/2006 |
FEI
NUMBER |
NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUED
TO: Robert
R. Petruzzi Plant Manager |
FIRM
NAME
Diamond Pet Food Processors of South
Carolina, LLC |
STREET
ADDRESS
100 WoodTrail Drive |
CITY,
STATE AND ZIP CODE
Gaston, SC 29053 |
TYPE
OF ESTABLISHMENT INSPECTED
Pet Food Manufacturer |
This document lists
observations made by the FDA representative(s) during the inspection
of your facility. They are inspectional observations, and do not
represent a final Agency determination regarding your compliance.
If you have an objection regarding an observation, or have implemented,
or plan to implement, corrective action in response to an observation,
you may discuss the objection or action with the FDA representative(s)
during the inspection or submit this information to FDA at the address
above. If you have any questions, please contact FDA at the phone
number and address above. |
DURING AN INSPECTION OF YOUR FIRM I OBSERVED:
Item #1: Aflatoxin testing of finished pet food product retention
samples of pet food manufactured between Sept 1, 2005 and Nov. 30,
2005 showed 16 batches of various pet food products with an Aflatoxin
level 20 ppb or greater. Examples of aflatoxin test results in some
of the product batches:
Batch Code |
Manufacturing Date |
Highest Aflatoxin Level in Retention Sample |
DPA1001G |
Oct 11, 2005 |
376 ppb |
DMD1001J |
Oct 11, 2005 |
280 ppb |
DMD1001K |
Oct 12, 2005 |
96 ppb |
DMD1001F |
Oct 4, 2005 |
75 ppb |
DPA0901O |
Oct 3, 2005 |
61 ppb |
|
Item #2: Outside laboratory aflatoxin testing of four accepted incoming
shipments of whole corn showed high levels of aflatoxin.
Weight Ticket |
Date Received |
Aflatoxin Level |
G19519 |
Sept. 16, 2005 |
90 ppb |
G20213 |
Oct. 11, 2005 |
1851 ppb |
G20828 |
Oct 31, 2005 |
111 ppb |
G21488 |
Nov. 21, 2005 |
123 ppb |
These whole corn shipments were used in the manufacturing
of various pet food products.
|
#3: Firm’s written procedures require each shipment of incoming
corn shipment be checked for aflatoxin. Records for the Aflatoxin
testing of incoming whole corn did not always document that the
tests were done or that the [ REDACTION ] test
was performing properly.
A. Confirmatory aflatoxin testing on whole corn retention
samples have found four incidences of false negative [ REDACTION
] tests and two false positive [ REDACTION ] tests.
For example:
Weight Ticket |
Date |
[ REDACTION ] Result |
2nd Test Result |
G19519 |
09/16/05 |
Negative |
90 ppb |
G20213 |
10/10/05 |
Negative |
1851 ppb |
G20828 |
10/31/05 |
Negative |
111 ppb |
G21488 |
11/21/05 |
Negative |
123 ppb |
G19764 |
09/26/05 |
Positive |
4 ppb |
G19840 |
09/28/05 |
Positive |
2 ppb |
B. The Incoming Ingredient Inspection
form did not list the results of the
[ REDACTION ] test for approximately 12 of the
[ REDACTION ] incoming whole shipments during September
and October 2005.
C. On Dec. 7, 2005 only nine of [ REDACTION
] shipments of whole corn were tested for Aflatoxin.
D. There was no documentation of running
a positive or negative control to ensure that the reagents of the
[ REDACTION ] test were functioning properly.
|
#4: As per the firm’s written procedures, retention samples
of all bulk materials (including whole corn) are to be collected.
Over 50% of the retention samples of incoming whole corn shipments
from Sept. 1, 2005 to Nov. 30, 2005 are missing. Quality Control
personnel who are responsible to ensure the collection and storage
of retention samples failed to notice the retention samples were
not being collected or were missing. Without the retention samples
there can be no secondary check for Aflatoxin in those incoming
corn shipments.
|
#5: Accepted incoming bulk feed ingredients do not always meet
the firm’s ingredient specifications. Some of these ingredient
specifications include ranges for protein, moisture, fat, ash, and
fiber. The five listed specifications are checked by Near InfraRed
Spectroscopy (NIR). Handwritten written results on the Receiving
NIR Test Results Report for the time period 1/3/06 to 1/17/06 indicated
that:
A. 17 of 21 accepted shipments of wheat flour failed
three or more of the five specifications tested by NIR.
B. All five accepted shipments of rice bran failed four
out of five specifications tested by NIR.
C. Six of seven accepted shipments of Chicken By-Product
Meal (Low Ash) failed all four specifications tested by NIR.
D. There was no documentation of NIR test results for
whole corn for 2005.
|
#6: Written procedures for receiving bulk materials do not reflect
current practices. For example, verbal directions were made to disregard
the black light testing of incoming corn shipments and test all
corn shipments for aflatoxin. The form, Incoming Ingredient Inspection,
for recording the inspection results of bulk material was changed
at the first part of 2005.
|
#7: No acceptance criteria or testing conducted on fines stored
outside in trailers.
|
#8: No BSE warning statement on invoice of pet food scrapes sold to
local hog farmer.
|
FDA EMPLOYEE'S NAME, TITLE, AND SIGNATURE:
[Handwritten Signature]
E. Harold Blackwood Investigator |
SEE
REVERSE
OF THIS
PAGE |
|
|
DATE
ISSUED 01/19/2006 |
FORM FDA 483 (7/00) PREVIOUS EDITION OBSOLETE
INSPECTIONAL OBSERVATIONS
Reverse Text on Page: The observations of objectional conditions and practices listed
on the front of this form are reported:
- Pursuant to Section 704(b) of the Federal Food, Drug and
Cosmetic Act, or
- To assist firms inspected in complying with the Acts and
regulations enforced by the Food and Drug Administration.
|
Section 704(b) of the Federal Food, Drug, and Cosmetic
Act (21 USC374(b)) provides: “Upon
completion of any such inspection of a factory, warehouse, consulting laboratory, or other
establishment, and prior to leaving the premises, the officer or employee making the
inspection shall give to the owner, operator, or agent in charge a report in writing
setting forth any conditions or practices observed by him which, in his judgement,
indicate that any food, drug, device, cosmetic in such establishment (1) consists in whole
or in part of any filthy, putrid, or decomposed substance or (2) has 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. A copy of such report
shall be sent promptly to the Secretary.” |
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