IA #57-15 - 5/20/02, IMPORT ALERT #57-15, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF ALLERGENS ***AND/OR ALLERGENIC PRODUCTS*** ATTACHMENT
REVISED 5/20/02
NOTE: This alert has been revised to create an attachment and
clarify the products covered. Additional changes are
bracketed by asterisks (***).
TYPE OF ALERT: Detention Without Physical Examination
NOTE: This import alert represents the Agency's current guidance
to FDA field personnel regarding the manufacturer (s) and/or
product(s) at issue. It does not create or confer any
rights for or on any person, and does not operate to bind
FDA or the public.
PRODUCT: Allergens (allergenic extracts)
Allergen delivery systems (allergy patches)
PRODUCT
CODE: See attachment
PROBLEM: No U.S. License and Misbranding
PAC: 45R800
PAF: REG
COUNTRY: Canada (CA)
Sweden (SE)
*** United Kingdom (GB)***
MANUFACTURER
/SHIPPER: ***See Attachment***
CHARGE: "The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that the labeling of the article does not
appear to contain adequate directions for use, and the article
does not appear to be exempt from such requirements.[Misbranding,
Section 502(f)(1)]."
AND
"The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that the article appears to be a biological
drug for which a biologics license is not in effect under Section
351 of the Public Health Service Act. [PHS Act, Section 351(a)]."
(OASIS Charge Codes: NO LICENSE; DIRECTIONS)
RECOMMENDING
OFFICE: CBER, Office of Compliance and Biologics Quality, Division of Case
Management, HFM-610
REASON FOR
ALERT: FDA has determined that the firms listed ***below*** have been
sending unlicensed allergens and/or ***allergenic products*** to
the U.S.
***Many allergenic products identified as part of Enzyme
Potentiated Desensitization or EPD treatments have been
misdeclared or inappropriately identified in previous entries as
enzymes, reagents, biochemicals, and dietary supplements.***
GUIDANCE: Districts may detain without physical examination the specified
biologic product(s) from the firms listed *** on the attachment to
this alert ***.
NOTE: (For Allergen Delivery Systems/Patches) - Allergen delivery
systems only that are pre-filled with allergenic extracts or
unfilled allergen delivery systems that accompany allergenic
extracts in shipping should be detained. Unfilled allergen
delivery system components are not subject to this guidance.
FOI: Purging between ^ ^ is required.
KEY WORDS: Allergen, allergy patches, allergen extract
PREPARED
BY: Stella Notzon, DIOP, (301) 443-6553
DATE LOADED
INTO FIARS: May 20, 2002
*** ATTACHMENT TO IMPORT ALERT # 57-15, Revised 5/20/02 ***
[FIRMS RECOMMENDED FOR DWPE]
Manufacturer Products Product Code
Chemotechnique Diagnostics All allergens and/or ^ ^
Malmo, Sweden allergenic products ^ ^
FEI # 3002096442 ^ ^
^ ^
^ ^
Chemotechnique Diagnostics All allergens and/or ^ ^
Box 80 allergenic products ^ ^
Tygelsjo, Sweden ^ ^
FEI # 3001620868 ^ ^
^ ^
Dormer Laboratories,Inc. All allergens and/or ^ ^
91 Kelfield Street #5 allergenic products ^ ^
Rexdale, Ontario, Canada ^ ^
M9W 5A3 ^ ^
FEI # 3001344828 ^ ^
McEwen Laboratories Enzyme Potentiated ^ ^
12 Horseshoe Park Desensitization ^ ^
Pangboorne, Berks, England products including: ^ ^
RG87JW United Kingdom Beta-glucuronidase ^ ^
FEI # 3001190779 Chondroitin X-Theta ^ ^
Chondroitin X-E
Chondroitin I-C
Chondroitin LA
Chondroitin W
Chondroitin Formalin
Chondroitin P/K.C.
Chondroitin O&E
Chondroitin T
Chondroitin Bacteriodes
Chondroitin M
Chondroitin D
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