IA #99-26, 4/4/07, IMPORT ALERT #99-26, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF WHEAT GLUTEN DUE TO THE PRESENCE OF MELAMINE"
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)]"
(Oasis Charge Code; POISONOUS)
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 to Cathie
Marshall, CVM, Division of Compliance, HFV-232, at (240)
276-9217.
Appropriate screening criteria have been set for wheat
gluten from China and the Netherlands, as a country through
which transshipping of Chinese wheat gluten may occur.
Sampling has been recommended. 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
Linda Wisniowski, DIOP, HFC-172, 301-443-6553
DATE LOADED
INTO FIARS: April 4, 2007 ATTACHMENT April 4, 2007
Firms and products currently under detention without physical examination
CHINA (CN)
Firm: Date DWPE Product/Code:
Xuzhou Anying Biologic Technology 4/4/07 Wheat gluten
Development Company Ltd. 02F[][]08
Wangdian Industrial Zone,
Peixian, CN-32, China 221623
FEI# 2000023594
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