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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Liberty Gold Fruit Company, Inc. 16-Jan-02

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

Detroit District

1560 East Jefferson Avenue

Detroit, MI 48207-3179

Telephone: 313-226-6260

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

WARNING LETTER

2002-DT- 19

January 16, 2002

Entry #: 231-6807097

Mr. Harry A. Battat, President

Liberty Gold Fruit Company, Inc. Product: Pineapple

500 Eccles Avenue

South San Francisco, CA 94080

Dear Mr. Battat:

On August 20, 2001 you imported canned pineapple tidbits and sliced pineapple under the referenced entry number. The Food and Drug Administration (FDA) collected a sampled of the article and a Notice of Sampling was issued on August 20, 2001. A Notice of Detention and Hearing charging that the article was misbranded under Section 403(q) of the Food, Drug and Cosmetic Act (the Act) was issued on August 29, 2001.

According to a November 5, 2001 letter from your attorney, the referenced entry consisting of [redacted] cases of pineapple tidbits and [redacted] cases of sliced pineapple, that had been detained by our office was distributed into commerce after receipt of the Notice of Sampling without a proper release from us, This is a violation of Title 21, Code of Federal Regulations, Section 1.0 (21 CFR 1.90) which requires the importer to hold an entry intact pending receipt of a May proceed or Release Notice from FDA. A Notice of Refusal of Admission (copy enclosed) for this entry was issued on September 25, 2001.

Failure to promptly correct this violation and to prevent future violations may result action 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 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. Your response should be directed to this office to the attention of Mr. John E. Klemmer, Compliance Officer.

Sincerely yours,

Joann M. Givens

District Director

Detroit District