Inspections, Compliance, Enforcement, and Criminal Investigations
Sea World, Inc. 22-Apr-08
Department of Health and Human Services
Public Health Service
San Juan District
April 22, 2008
Return Receipt Requested
Mr. Eric Charack, President
Sea World, Inc.
PO Box 361986
San Juan, PR 00936-1986
Dear Mr. Charack:
We inspected your seafood importer establishment, located at 36 Diana Street, Amelia Industrial Park, Guaynabo, Puerto Rico on February 27-28, 2008. 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 and 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 and fishery products have been processed under conditions that are equivalent to those required of domestic processors under 21 CFR Part 123, the fish and 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 from 21 CFR Part 123, your snapper, grouper, mahi mahi, conger (eel), and corvine 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:
1. You must implement an affirmative step which ensures that the fish and fishery products you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2)(ii). However your firm did not perform an affirmative step for the snapper, grouper, mahi-mahi, conger (eel), and corvine that you import from [(b)(4)] and [(b)(4)] both located in [(b)(4)]. The affirmative step may include any of the following:
(A) Obtaining from the foreign processor the HACCP and sanitation monitoring records required by this part that relate to the specific lot of fish or fishery products being offered for import; or
(B) Obtaining either a continuing or lot-by-lot certificate from an appropriate foreign government inspection authority or competent third party certifying that the imported fish or fishery product is or was processed in accordance with the requirements of this part; or
(C) Regularly inspecting the foreign processor's facilities to ensure that the imported fish or fishery product is being processed in accordance with the requirements of this part; or
(D) Maintaining on file a copy, in English, of the foreign processor's HACCP plan, and a written guarantee from the foreign processor that the imported fish or fishery product is processed in accordance with the requirements of the part; or
(E) Periodically testing the imported fish or fishery product, and maintaining on file a copy, in English, of a written guarantee from the foreign processor that the imported fish or fishery product is processed in accordance with the requirements of this part; or
(F) Other such verification measures as appropriate that provide an equivalent level of assurance of compliance with the requirements of this part.
In addition, the Food and Drug Administration has determined that your facility is subject to the registration requirement in Section 415 of the Act (21 U.S.C. § 350d) and our implementing regulation at 21 CFR Part 1, Subpart H. The failure to register a facility as required is a prohibited act under Section 301(dd) of the Act (21 U.S.C. § 331(dd). Our records indicate that, to date, your facility has not been registered with FDA.
The owner, operator, or agent in charge of your facility, or an individual authorized by your facility's owner, operator, or agent in charge, should register the facility with FDA immediately. Registration may be accomplished on-line at http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number.
Alternatively, the owner, operator, or agent in charge of this facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537. This form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575-0156, or by writing to the agency at the following address:
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
When completed, the form may be faxed to (301) 210-0247 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number using the same method used to submit the registration to FDA.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to 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.
Your written reply should be addressed to the Food and Drug Administration, Attention: Carlos I. Medina, Compliance Officer, at 466 Fernandez Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions concerning the violations noted please contact Mr. Medina at (787) 474-9539.
San Juan District