Import Alert 57-15
(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(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).
Import Alert # 57-15
Published Date: 01/14/2016
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Allergens And/Or Allergenic Products"
Reason for Alert:
NOTE: Revision of this Import Alert dated 01/14/2016 changes the CHARGES section and updates language in the GUIDANCE section. Changes are noted and bracketed with three asterisks (***).
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.
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 in the Red List in 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.
***For questions regarding these criteria and/or products covered, contact
CBER's Office of Compliance and Biologics Quality, Division of Case Management at 240-402-9155.***
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.
***For questions regarding these criteria and/or products covered, contact
CBER's Office of Compliance and Biologics Quality, Division of Case Management at 240-402-9155.***
Product Description:
Allergens (allergenic extracts)
Allergen delivery systems (allergy patches)
PRODUCT CODES: 57[][][][][]Bio & Licensed In-Vivo & In-Vitro Diag,
Desc: All allergenic and allergenic products
Allergen delivery systems (allergy patches)
PRODUCT CODES: 57[][][][][]Bio & Licensed In-Vivo & In-Vitro Diag,
Desc: All allergenic and allergenic products
Charge:
***"The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use.
[Misbranded, 801(a)(3), 505, 502(f)(1); UNAPPROVED, MISBRANDED & PHS ACT]
OASIS Charge Code: NO LICENSE***
[Misbranded, 801(a)(3), 505, 502(f)(1); UNAPPROVED, MISBRANDED & PHS ACT]
OASIS Charge Code: NO LICENSE***
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)
CANADA
Dormer Laboratories Inc
Date Published : 09/10/2009
91 Kelfield St Unit 5
, Etobicoke,
Ontario CANADA
57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag
Date Published: 05/14/2010
Desc: All allergens and allergenic products
Notes: Other product codes:
b(7)(a)
b(7)(a)
b(7)(a)
b(7)(a)
b(7)(a)
SWEDEN
Chemotechnique Diagnostics
Date Published : 09/10/2009
Unknown Street
, Malmo,
SWEDEN
57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag
Date Published: 05/14/2010
Desc: All allergens and allergenic products
Notes: Other product codes:
b(7)(a)
b(7)(a)
b(7)(a)
b(7)(a)
b(7)(a)
Chemotechnique Diagnostics
Date Published : 09/10/2009
Box 80 28042
, Tygelsjo,
SWEDEN
57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag
Date Published: 05/14/2010
Desc: All allergenic and allergenic products
Notes: Other product codes:
b(7)(a)
b(7)(a)
b(7)(a)
b(7)(a)
b(7)(a)
UNITED KINGDOM
Mcewen Laboratories Limited
Date Published : 05/14/2010
12 Horseshoe Park,
, Reading,
UNITED KINGDOM
57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag
Date Published: 05/14/2010
Desc: Enzyme potientiated desentization products including 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
Notes: Other product codes:
b(7)(a)
b(7)(a)
b(7)(a)
b(7)(a)