Posted on 04/01/2007 4:49:58 PM PDT by Milwaukee_Guy
IA #99-26, IMPORT ALERT #99-26, "DETENTION WITHOUT PHYSICAL EXAMINATION AND INTENSIFIED COVERAGE 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
PROBLEMS: Poisonous or deleterious substance Unsafe food additive
PAF: PES FAD
PAC FOR COLLECTION: 71003A 09006A
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)
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)]" (Oasis Charge Code: UNSAFE ADD)
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 sour ce 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 and Linda Wisniowski, DIOP, HFC-172, 301-443-6553
DATE LOADED INTO FIARS: March 30, 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
Why do we import food from China?
This is just plain idiotic. All these dog food and cat food companies need to be sued for their short-term financial greed that led to the death of these animals. Bet buying from China looked good on their financial reports. Idiots.
FOR THE LOVE OF PETS, BUMP!
I think you are correct,,,"Bulk-Carrier" that didn't get
cleaned out good,,,Holland to China and back to the US...?
Every time I hear about this stuff from China, I hate Bill Clinton just a little more.
ROFLMAO!!!
You are so creative...terrific! Cat PoiSon!ha.
Aren't we subsidizing our farmers? what the F....k is going on?
We are Paying to get poisoned? TWice..here and the imports?
Thank you. :)
Organic food from China means it was fertilized with peasant poop.
Same reason US companies fire US employees and hire Chinese and Indians -- their CFOs are eager for a few more bucks. It may look good short-term, but results in decreased quality and eventually (hopefully!) lower profits.
The short answer: $$$
I hope so.
Oh, great.
Get in on the lawsuits!!! these people need to be taught a lesson.
I am so sorry for your loss. I don't know what I would do if my darling Lola, the pupster, were to die. And then to know it was greed that did it.
"Freedom Kibble", anyone?
Someone needs to archive this website before it disappears.
Yes, mostly we pay them not to plant to keep prices up. It is even done with corn right now for the upcoming season despite increased demand from ethanol production.
Did you mean their "engrish" web site?
You could get Banh Bao-ed for that.
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