Inspections, Compliance, Enforcement, and Criminal Investigations
Omar Seafood, Corp 5/9/11
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
RETURN RECEIPT REQUESTED
May 9, 2011
Mr. Clemente O. Villar
Omar Seafood, Corp
2111 NW 10th Ave
Miami, FL 33127
Dear Mr. Villar:
The United States Food and Drug Administration (FDA) inspected your seafood facility, located at the above address from February 9, 2011 to February 10, 2010. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). The specific requirements for imported fish and fishery products are set out in 21 CFR 123.12. As an importer of fish or fishery products, you must operate in accordance with the requirements of Part 123. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), and will be denied entry. Because our inspection identified serious violations for 21 CFR Part 123, your fresh whole gutted fish including snapper, and grouper are adulterated under Section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4), in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violation was as follows:
• You must implement an affirmative step designed to ensure that the fish and fishery products you import into the United States were processed in accordance with the requirements of FDA's seafood HACCP regulations, to comply with 123.12(a)(2)(ii).
(a.) However, your firm did not implement an affirmative step for the importation of whole gutted snapper and grouper imported from foreign processor (b)(4) and (b)(4) dba
We acknowledge your response dated February 17, 2011, to the FDA 483 issued February 10, 2011 however we deem it inadequate in that the foreign HACCP plan you included for (b)(4) is in Spanish. 21 CFR Part 123.12(0) specifically states that the foreign processor's HACCP plan must be in English. In addition you failed to include the documentation in English that verifies you have an affirmative step in place for your foreign processor (b)(4) (i.e. you failed to include a copy in English of the HACCP plan or other documentation indicating how you have implemented the required affirmative step). We requested this additional documentation from you on March 2, 2011, yet you have failed to respond.
We may take further action if you do not promptly correct this violation. For instance, we may refuse admission of your imported fish or fishery products under Section 801(a) of the Act, 21 U.S.C. § 381(a), including placing them on "detention without physical examination," seize your product(s) and/or enjoin your firm from further violating the Act.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation, such as HACCP and importer verification records and records that document the performance and results of your firm's affirmative steps, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
This letter may not list all the violations at your facility. You are responsible for ensuring that your seafood importer establishment operates in compliance with the Act and the seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for the fish or fishery products that you import into the United States.
Please send your written reply to the Food and Drug Administration, Attention: Carla Norris, Compliance Officer, 555 Winderley Place, Suite 200, Maitland Florida 32750. If you have any questions regarding this letter, please contact Carla Norris at (407)475-4730.
Emma R. Singleton
Director, Florida District