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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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AvoCo International LLC 25-Apr-03

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Southwest Import District
4040 North Central XPY
Suite 300
Dallas, Texas 75204
Telephone: (214)253-5200
Fax: (214)253-5318


April 25, 2003

Ref: 2003-SWID-WL-7

WARNING LETTER

VIA FEDERAL EXPRESS

Mr, Jerry D. Remien, Vice President
AvoCo International Llc.
10600 Higgins Road, Suite 405
Rosemont, IL 60018

Regarding: Entry [redacted]

Dear Mr. Remien,

The Food and Drug Administration (FDA), on 11/12/02, detained a shipment of [redacted] cartons of Avocado Guacamole Pulp, see enclosed Notice of FDA Action dated 11/13/02. The shipment had been offered for Import (imported) into the United States by your firm under Customs' Entry Number [redacted] on October 7, 2002. FDA refused admission of the shipment on December 10, 2002, see enclosed Notice of FDA Action dated December 10, 2002. On 3/27/03 FDA learned that the shipment had been distributed into U.S. commerce without a proper FDA release and despite the FDA detention and refusal of admission. Title 21 Code of Federal Regulations, Section 1.90 requires the importer, after receipt of the notice described there, to hold an imported article and not distribute it pending receipt of the results of examination of the sample.

We have requested that U.S. Customs Service order redelivery of the goods which were distributed Without a FDA release. Fai1ure to redeliver the entire shipment to Customs custody may result in the assessment of liquidated damages.

Future premature distributions of Imported product may result In United States Customs Service requiring that future import shipments by your firm be held in secured storage. Such secured storage would be under the supervision and direction of the United States Customs Service, such as in a bonded warehouse. Your firm would be responsible for all costs incurred in secured storage.

In addition, FDA laboratory analysis determined that the avocado pulp contained Listeria monocytogenes and is adulterated under 21 USC 342 (a)(1), in that it bears or contains a poisonous or deleterious substance which renders it injurious to health.

Finally, your firm has committed a prohibited act under 21 USC 331 (a), by the introduction or delivery for introduction into interstate commerce of any food, drug, or Cosmetic that is adulterated.

It is your responsibility, as the importer,to ensure that imported products meet all the requirements of the Federal Food, Drug, and Cosmetic Act and the regulations promulgated there under.

We request a response in writing within fifteen (15) working days of receipt of this letter outlining the specific steps you have taken to prevent recurrence.

Your written reply should be addressed to the Food and Drug Administration. Attention: Brian Ravitch, Compliance Officer, 2324 Paseo De Las Americas, Suite 200, San Diego, CA 92154.

Sincerely,

/S/

Robert J. Deininger
District Director