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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Pet Magic, Inc. 17-Oct-01

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
Detroit District Office
Central Region
1560 East Jefferson Avenue
Detroit MI 48207-3179
Telephone: (313) 226-6260
FAX: (313) 226-3076

CERTIFIED MAIL
RETURN RECEIPT REQUESTED
October 17, 2001
WARNING LETTER
2002-DT-06
Entry #: 551-1459069-3
Product: Pig Ear Dog Treats

Mr. Louis A. Rodriguez, Vice President
Pet Magic Inc.
15510 Dale Street
Detroit, MI 48223

Dear Mr. Rodriguez:

Inspector Marcus Head made an inspection of your firm on September 27, 2001 in follow up to a Food and Drug Administration (FDA) analysis of a sample from the referenced entry that was found positive for Salmonella. The inspection found that the referenced entry of pig ear dog treats, consisting of [redacted] 300 ear cartons that had been detained by our office on September 21, 2001, was distributed into commerce without a proper release from the FDA. Our inspection found that [redacted] cartons were distributed prior to completion of the FDA analysis and the issuance of the detention. Your firm initiated a recall of the distributed product as a result of our inspection.

Your distribution of this product is a violation of Title 21, Code of Federal Regulations. Part 1.90 (21 CFR 1.90), which requires the importer to hold an entry intact pending receipt of a May Proceed or Release Notice from the FDA. We have requested the U.S. Customs Service (Customs) to order redelivery of this shipment (copy enclosed).

Failure to promptly correct this violation and prevent future violations may result in regulatory action without further notice such as seizure, injunction or detention without examination of future shipments. It is your responsibility, as the importer; to ensure that imported products meet all requirements of the Federal Food, Drug and Cosmetic Act and the regulations promulgated thereunder.

Please notify us in writing, within fifteen(15) working days of the receipt of this letter, of the steps you have taken to correct the violation, including an explanation of each step being taken to prevent its recurrence. In addition, please state the intended disposition of the products from this entry that you are currently holding at your firm. Your response should be directed to this office to the attention of Mr, John E. Klemmer, Compliance Officer.

Sincerely yours,
David M. Kaszulski for
Joann M. Givens
District Director
Detroit District