Xuzhou Anying Biologic Technology Development Co. Ltd. web site

RECALLED PRODUCT:

Tainted wheat gluten supplied to ChemNutra.

PRESS RELEASES: 

3/30/07 (Updated by FDA 4/19/07):

FDA Import Alert IA9926

IA #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:         02F[][]08   Wheat gluten
               02E[][]06 - Wheat flour gluten
               71M[][]01   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.                     02F[][]08
Wangdian Industrial Zone,
Peixian, CN-32, China 221623
FEI# 2000023594