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