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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Pioneer International 20-Jun-02

Department of Health and Human ServicesDepartment of Health and Human Services            Public Health Service


San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephcne: 510-337-6700

VIA FEDERAL EXPRESS

June 20, 2002

Our Reference: Entry Number MX7-0708834-4, lines 001/001 and 005/001

Yaswant Singh, CEO / President
Pioneer International
8017 36th Avenue
Sacramento, CA 95824-5310

WARNING LETTER

Dear Mr. Singh:

On May 21, 2002, we attempted to sample a shipment of mahi-mahi and duruka (entered as "asparagus"), in accordance with Notice of FDA Action dated May 15, 2002 and found the shipment was not available, having already been sold. The shipment was offered for import into the United States by your firm on May 14, 2002 under entry number MA7-07078834-4.

The action taken by your firm is a violation of Title 21, Code of Federal Regulations, Section 1.90 (21 CFR 1.90), which requires the importer to hold an entry intact pending receipt of a May Proceed or Release Notice. We are hereby requesting U. S. Customs to order redelivery of the part of this shipment that was not held (copy enclosed).

Failure to promptly correct this violation and prevent future premature distribution of imported products may result in requiring that future shipments be held in secured storage. Secured storage will be under the supervision and direction of the U.S. Customs Service, such as in a bonded warehouse. You would be responsible for all costs incurred in secured storage.

Within fifteen working days of receipt of this letter, notify this office in writing of the specific steps you have taken to correct the violation, including an explanation of each step being taken to prevent the recurrence of the violation. In addition, you should inform U.S. Customs and FDA if and when redelivery is accomplished.

Your written reply should be addressed to:

Charles D. Hoffman, Compliance Officer
U.S. Food and Drug Administration
1431 Harbor Bay Parkway
Alameda, CA 94502

You may fax your response to Mr. Hoffman at: 510-337-6707.

Sincerely,

/s/

Janet Codor for Dennis K. Linsley

District Director

San Francisco District