Inspections, Compliance, Enforcement, and Criminal Investigations
FAVPEP LLC. dba Queenmar LLC. 6/26/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|555 Winderley Pl., Ste. 200
Maitland, FI 32751
June 26, 2009
Mr. Miguel Boutureira
FAVPEP, LLC Dba Queenmar
1463 NW 9th Avenue
Miami, Florida 33172
Reference: Customs Entry no. EDX-0007792-5
Product: Frozen Crabmeat
Dear Mr. Boutureira:
On October 27, 2008, the Food and Drug Administration (FDA) issued a Notice of FDA Action to you, advising you that it would be examining the shipment of 420 containers of frozen crabmeat that you were offering for import into the United States under Customs Entry number EDX-0007792-5. On October 28, 2008, FDA representatives collected a sample from the shipment. The frozen crabmeat sampled was analyzed to determine compliance with the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC §§ 301 et seq.]. FDA analysis of the frozen crabmeat found that the product was contaminated with Salmonella spp., a poisonous or deleterious substance which may render the product injurious to health. Presence of the Salmonella caused the product to be adulterated within the meaning of section 402(a)(1) of the Act [21 USC § 342(a)(1)]. The product was detained on November 06,2008, and subsequently refused entry on December 05, 2008.
On January 29, 2009, FDA attempted to supervise the destruction of the 420 containers of crabmeat at the South Miami-Dade Solid Waste Disposal Facility, Gould, Florida. Based upon its examination, FDA concluded that the crabmeat presented for destruction was not the product which was originally entered by you. The evidence gathered by the FDA investigator revealed that the retail-sized, 1-lb containers were completely different from, the containers that FDA originally sampled on October 28, 2008. Furthermore, the follow-up investigation conducted by FDA's investigator established that the product you presented for destruction was, indeed, substituted for your adulterated product. Specifically, on February 18, 2009, you stated to FDA representatives that the product presented for destruction was part of an older shipment of crabmeat. You informed FDA investigators that on December 23, 2008, the crabmeat offered for import under Customs Entry number EDX-0007792-5 and subsequently found by FDA to be contaminated with Salmonella was distributed and sold to (b)(4).
Section 801 (a)(3) of the Act [21 U.S.C. 381 (a)(3)] requires that imported articles be refused admission when it appears from examination of samples, or otherwise, that the articles are adulterated. Your 420 containers of crabmeat, entry EDX-0007792-5, were refused admission on this basis. Section 801(a) also provides for the destruction of any such articles refused admission, unless they are lawfully exported within 90 days of the date of the notice of refusal of admission.
It is your responsibility, as an importer, to ensure that imported products meet all the requirements of the Federal Food, Drug, and Cosmetic Act and regulations promulgated thereunder and to ensure that the products you distribute are not adulterated and are otherwise in compliance with the law. You distributed the adulterated crabmeat in violation of Section 301(c) of the Act [21 U.S.C. 331(c)].
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 may be seized by U.S. Customs and Border Protection under Title 19, section 1595a(c) and civil monetary penalties may be assessed under Title 19 section 1595a(b). Liquidated damages may also be assessed for articles not redelivered.
Please provide a response in writing within fifteen (15) working days of receipt of this letter outlining the specific steps you have taken to correct the violation, including an explanation of each step being taken to prevent recurrence of distribution of goods subject to refusal. Your written reply should be addressed to the Food and Drug Administration, Attention: Lidia Diaz-Castaneda, Compliance Officer, 6601 NW 25th St. Suite 241, Miami, FL 33122.
Emma R. Singleton
Director, Florida District