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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Laureano Gerardo Flores 21-Mar-03

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

Public Health Service
Food and Drug Administration

 

Southwest Import District
Southwest Region
4040 North Central Expressway
Suite 300
Dallas, Texas 75204


March 21, 2003

Ref: 2003-SWID-W&-4

WARNING LETTER

VIA FEDERAL EXPRESS

Mr. Laureano Gerardo Flores, Owner
501, N. Bridge St., Suite 565
Hidalgo, TX 78557

Dear Mr. Flores:

On January 28, 2003, our investigators inspected a shipment of [redacted] cases and [redacted] sacks of peppers invoiced and declared to FDA as dried Guajillo peppers, under entry number [redacted] 0078528-3, from the exporter Clemente Trevino Gonzalez. Our inspection revealed the actual product to be: [redacted] cases of dried Pasilla peppers, [redacted] cases of dried Ancho peppers, and [redacted] sacks of dried Guajillo peppers. The cases containing the dried Pasilla and Ancho peppers are misdeclared and are marked as "Guajillo." Guajillo peppers from Clemente Trevino Gonzalez are currently listed as exempt from Detention Without Physical Examination under Import Alert # 24-11. The dried Pasilla and Ancho peppers are both subject to Detention Without Physical Examination.

The misrepresentation of this product at the time of entry appears to be an attempt to circumvent our Detention Without Physical Examination action against the dried Pasilla peppers and Ancho peppers shipped by Clemente Trevino Gonzalez as covered by Import Alert #24-11. In addition, food is deemed misbranded under section 403 (a)(1) of the Federal Food, Drug, and Cosmetic Act if its labeling is false or misleading. The dried Pasilla and Ancho peppers are misbranded because they are labeled as Guajillo peppers.

As a result, we have recommended that the U.S. Customs Service require that future shipments of food imported by your firm be held in secured storage. Secured storage will be under the supervision and direction of U.S. Customs, such as in a bonded warehouse. You will be responsible for all costs incurred at secured storage.

Within 15 working days of receipt of this letter, notify this office in writing of the specific steps you have taken to correct this violative situation, including an explanation of each step being taken to prevent the recurrence.

Your reply should be directed to Mr. Alexander Lopez, Acting Compliance Officer, U.S. Food and Drug Administration, 715 Bob Bullock Lp., Rm. 75, Laredo, TX 78045.

Sincerely,
/s/
Robert J. Deininger
District Director