Inspections, Compliance, Enforcement, and Criminal Investigations
Sea World, Inc. 5/1/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Juan District
466 Fernández Juncos
San Juan, Puerto Rico
May 1, 2012
Mr. Danny Charak
Sea World, Inc.
#11 Crown Bay
St. Thomas, VI 00804
Dear Mr. Charak:
The United States Food and Drug Administration (FDA) inspected your seafood warehouse establishment located at #11 Crown Bay, St. Thomas, VI 00804, from March 26, 2012 through March 27, 2012. 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 123). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4).
Accordingly, your seafood products, including your pasteurized canned crabmeat products, are adulterated, in that they have been held under unsanitary 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 violations were as follows:
1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you held in storage to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). Your firm does not have a HACCP plan for your-ready-to-eat pasteurized canned crabmeat products that you receive refrigerated in cans, to control the food safety hazard of Clostridium botulinum growth and toxin formation during the period the product is being held under refrigerated conditions in the sealed cans. We note that you also receive at your warehouse other seafood products at frozen temperatures; and occasionally you may receive fresh fish. For any seafood products that you receive and hold for distribution, you must conduct or have conducted for you a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur, and have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b).
2. You must have a HACCP plan that lists the critical control points for each identified food safety hazard to comply with 21 CFR 123.6(c)(2); and establishes the critical limits that must be met at each identified critical control point to comply with 21 CFR 123.6(c)(3). However, your firm has not developed nor implemented a HACCP plan for your pasteurized canned crab meat product nor for any of your other products, including a variety of fresh (tuna, mahi-mahi and swordfish) and frozen (shrimp, tuna, snapper) seafood products. There is not a HACCP plan listing the temperature limits at the "receiving" and "storage" activities, adequate to control the hazard of pathogen growth and potential toxin formation, including, for example, the formation of Clostridium botulinum toxin.
3. You must calibrate your process-monitoring instrument to comply with 21 CFR 123.8(a)(2); and accordingly, you must review the records that document the calibrating of any process control instruments used at critical control points to comply with 21 CFR 123.8(a)(3).
4. You must maintain sanitation control records that, at a minimum, document your monitoring activities to comply with 21 CFR 123.11(b) and 21 CFR 123.11(c).
We also note that you receive your fresh, refrigerated and frozen seafood products from a supplier located in Guaynabo, Puerto Rico. When conducting your hazard analysis for each kind of fish and fishery products that you process to determine whether there are food safety hazards that are reasonably likely to occur, refrigerated transport of seafood products to your firm may be critical in controlling a hazard. FDA recommends continuously monitoring time and temperatures during refrigerated transport longer than 4 hours to your firm. Monitoring temperatures at receipt is only appropriate when transit times for the products are short, such as when products are in transit less than 4 hours.
We may take further action if you do not promptly correct these violations. For instance, we may take action to seize your product(s) and/or enjoin your firm from operating. At the conclusion of the inspection on March 27, 2012, you verbally promised our Investigator that you would immediately begin correcting the referenced deviations. However, as of the date of this letter, we have not received a written response from you.
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 plan, sanitation monitoring records, and importer verification 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) and the Current Good Manufacturing Practices regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for your fish or fishery products, including those that you import into the United States.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs mean all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please send your reply to the Food and Drug Administration, Attention: Marilyn Santiago, Acting Compliance Officer, at 466 Fernández Juncos Avenue, San Juan, PR 00901-3223. If you have questions regarding any issues in this letter, please contact Mrs. Santiago via email at Marilyn.Santiago@fda.hhs.gov or via telephone at (787) 474-9535.
San Juan District