Walker's Fruit Basket & Press 12-Dec-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

New York District

Food & Drug Administration

300 Pearl Street Suite 100

Buffalo, NY 14202

WARNING LETTER NYK 2002-17

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

December 12, 2001

Mr. Richard Walker, Owner

Walker?s Fruit Basket & Press

2860 Route 39

Forestville, New York 14062-9668

Dear Mr. Walker:

The Food and Drug Administration (FDA) has information which shows your firm violated the Federal Food, Drug, and Cosmetic Act.

On or about September 17, 2001 your firm imported grape juice into the United States under Entry No. 257-0986484-4 and Entry Number 257-0986485-1. An investigation conducted by this office revealed both entries were not held intact and part of the referenced grape juice has been distributed. In addition, we have learned sugar was added to the grape juice upon receipt.

We have requested U.S. Customs to order redelivery of the entries.

This action taken by your firm is in violation of 21 CFR 1.90, which requires an importer to hold an entry intact pending receipt of a "May Proceed" or "Release Notice" from the FDA. A "Release" by the U.S. Customs Service is a conditional release, which merely to take permits you possession of the shipment. When other Federal Agencies, such as the FDA, also exercise jurisdiction over a product offered for importation, their release must be obtained before a product may be legally distributed.

Failure to promptly correct these violations and prevent future violations may result in regulatory action without future notice, such as seizure or automatic detention, to ensure that imported products are held intact until released by FDA. It is your responsibility, as the owner/importer, to ensure imported products meet all requirements of the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder. Within fifteen (15) working days of the receipt of this letter, please notify our office in writing of

the specific steps you have taken to correct the violation(s), including an explanation of each step being taken to prevent a recurrence of the violation(s). Your response should be directed to Mark P, Prusak, Supervisory Investigator.

If you require further information, you may contact Mark P. Prusak at (716) 551-4461, Extension 3153.

Sincerely,

Jerome G. Woyshner

District Director