Inspections, Compliance, Enforcement, and Criminal Investigations
Dos Amigos Distributors, Inc. 12-Oct-04
Department of Health and Human Services
Public Health Service
Southwest Import District
October 12, 2004
Mr. Pablo Paoii, President
DosAmigos Distributors, Inc.
8595 Avenida Costa Sur, Suite A
San Diego, CA 92154
Dear Mr. Paofi:
On or about July 2, 2003, your firm DosAmigos Distributors, Inc., offered for import into the United States [redacted] cases of [redacted] Chocolate Beverage Powder under customs entry 218-0154515-9 (line 1/1). On July 11, 2003, the U.S. Food and Drug Administration (FDA) notified your firm that the Beverage Powder appeared to be misbranded under Section 403 of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 343, and that the product was subject to refusal of admission pursuant to Section 809(a)(3) of the Act, 21 U.S.C. § 381(a)(3). Your firm submitted no information to ovencome the appearance of this violation and the product was subsequently refused admission on August 4, 2003. Redelivery of the product for exportation or destruction as required by Section 801(a) of the Ad,21 U.S.C. § 381(a), was demanded by Customs and Border Protection on August 7, 2003.
Pursuant to this demand for redelivery, your firm presented a shipment of [redacted] for export to Mexico on September 9, 2004, at the Otay Mesa Commercial Port of entry in San Diego, California. Upon examination of the merchandise presented for exportation, FDA documented that different product was substituted for the actual refused product. Specifically, the Beverage Powder that was redelivered for exportation was found by FDA investigators to have lot codes different from that of the original product imported on or about July 2, 2003. In addition, on September 16, 2004, [redacted] signed an affidavit and supplied FDA with invoices of sale for the original [redacted] cases of [redacted] Chocolate Beverage Powder that were actually refused admission by FDA.
The introduction or delivery for introduction into interstate commerce of a misbranded food violates Section 301(a) of the Act, 21 U.S.C. § 331(a). Moreover, knowingly importing merchandise contrary to law or selling imported merchandise known to have been imported contrary to law violates Title 18, United States Code, Section 545. It is also a crime under Title 18, United States Code, Section 1001 to make false or fraudulent statements to federal officials. Criminal offenses can result in imprisonment or fines or both. Further, when evidence demonstrates that an article presented to FDA for examination is not from the original entry but was substituted for the entry, the article maybe seized under 19 U.S.C. § 1595a(c), andliquidated damages maybe assessed for any articles not redelivered.
It is your responsibility as the importer to ensure that Imported products meet all requirements of the Act and the regulations promulgated there under.
Failure to prevent future violations of this nature may result in regulatory action without further notice such as seizure, injunction, and/or prosecution.
Please notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct these violations, including an explanation of each step being taken to prevent the recurrence of these violations. Your written reply should be addressed to the Food and Drug Administration, Attention: Brian Ravitch, Compliance Officer, 2320 Paseo De Las Americas, Suite 200, San Diego, California 92154.
Robert J. Deininger
Director, Southwest Import District