Tainted wheat gluten supplied to ChemNutra.
FDA Import Alert IA9926IA #99-26, 4/19/07, IMPORT ALERT #99-26, "DETENTION WITHOUT PHYSICAL EXAMINATION OF WHEAT GLUTEN DUE TO THE PRESENCE OF MELAMINE" Revision to this import alert includes the unsafe food additive and unfit for food charges and deletes the OASIS charge codes. New information is designated 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 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). PRODUCT: Wheat Gluten PRODUCT CODES: 02F08 Wheat gluten 02E06 - Wheat flour gluten 71M01 wheat gluten PROBLEM: Poisonous or deleterious substance PAF: PES PAC FOR COLLECTION: 04R853 71R853 COUNTRY: See Attachment MANUFACTURER/ FEI#: See Attachment CHARGES: "The article is subject to refusal of admission pursuant to section 801(a)(3)in that it appears to bear or contain a poisonous or deleterious substance, which may render it injurious to health [Adulteration, section 402(a)(1)]" and/or *** "The article is subject to refusal of admission pursuant to section 801(a)(3)in that it appears to bear or contain a food additive that is unsafe within the meaning of section 409 [Adulteration, section 402(a)(2)(C)(i)]" and/or *** "The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be unfit for food [Adulteration, 402(a)(3)]" RECOMMENDING OFFICE: Division of Compliance, CVM (HFV-230) REASON FOR ALERT: In March 2007, FDA became aware of the illness and death of cats and dogs associated with certain pet food. Subsequently, samples of the implicated pet food were analyzed and found to contain melamine. The consumption of pet food containing melamine may be associated with acute renal failure in cats. Investigations have revealed that the source of the melamine was wheat gluten which is an ingredient in the pet food. The attachment to this alert includes manufacturers whose wheat gluten products have been found to contain melamine. GUIDANCE: Districts may detain without physical examination, products offered for importation from manufacturers and shippers listed in the Attachment to this import alert. Report wheat gluten samples found positive for melamine for animal food use to Cathie Marshall, CVM, Division of Compliance, HFV-232, at (240)276-9217 ****and positive samples for melamine for human food use to Salvatore Evola, CFSAN, Division of Enforcement, HFS-606, at (301)436-2164. Appropriate screening criteria has been input in OASIS. Recommendations for detention without physical examination of firms with violative product should be forwarded to DIOP, HFC-170. For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact Tom Savage, Division of Field Science, at 301-827-1026. To enable the agency to assess whether the firm has identified the source of the problem, and has taken the appropriate steps to correct and prevent future occurrences, FDA recommends that a firm requesting removal from detention without physical examination provide the following information: 1. a. Results of the firm's investigation(s) into the problem of melamine contamination b. Documentation showing corrective action(s)such as: i. a description of the process(es) currently being used ii. verification that the process is adequate iii. measures that have been taken to prevent recontamination c. Copies of three (3) production records showing the process, quantities processed, lot numbers and dates of processing. AND d. Documentation showing that a minimum of five (5) consecutive entries have been released by FDA based on third party laboratory analyses that show the shipments of wheat gluten do not contain melamine. All requests for removal from DWPE should be forwarded to DIOP,(HFC-170) which in turn will forward the requests to CVM (HFV-230) for evaluation. PRIORITIZATION GUIDANCE: I FOI: No purging required KEYWORDS: Feed, pet food, melamine, wheat gluten PREPARED BY: Cathie Marshall, CVM, HFV-232, 240-276-9217 and Linda Wisniowski, DIOP, HFC-172, 301-443-6553 DATE LOADED INTO FIARS: April 19, 2007 ATTACHMENT 3/30/07 Firms and products currently under detention without physical examination CHINA (CN) Firm: Date DWPE Product /Code: Xuzhou Anying Biologic Technology 3/30/07 Wheat gluten Development Company Ltd. 02F08 Wangdian Industrial Zone, Peixian, CN-32, China 221623 FEI# 2000023594