Inspections, Compliance, Enforcement, and Criminal Investigations
Supreme Lobster & Seafood Co. 15-Mar-06
Department of Health and Human Services
Public Health Service
March 15, 2006
RETURN RECEIPT REQUESTED
Dominic P. Stramaglia
President and CEO
Supreme Lobster & Seafood Co.
220 E. North Ave.,
Villa Park, IL 60181
Dear Mr. Stramaglia :
The Food and Drug Administration (FDA) conducted an inspection of your establishment located at 220 E. North Avenue, Villa Park, Illinois on February 2, 8, and 14, 2006. The inspection was conducted to determine your firm's compliance with FDA's seafood HACCP regulations, pursuant to Title 21, Code of Federal Regulations, Part 123 (21 CFR 123).
During the inspection, the FDA investigators observed serious deviations in your seafood HACCP program, including failure to comply with the importer verification requirements listed in the seafood HACCP regulation, 21 CFR Part 123.12, "Special Requirements for Imported Products." The FDA investigators also provided you with a copy of the FDA 483, Inspectional Observations (copy enclosed), which presents an evaluation of your firm's performance regarding various aspects of the HACCP requirements. 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 products have 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) in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. Because our inspection identified serious violations of 21 CFR Part 123, your direct import products, including shrimp from [redacted] and various finfish from[redacted] are adulterated under Section 402(a)(4) of the Act. You may find the Act, the seafood HACCP regulations 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 have product specifications that are designed to ensure that the fish and fishery products you import are not injurious to health, to comply with 21 CFR 123.12(a)(2)(i). However, your firm does not have product specifications for frozen cooked shrimp imported from [redacted] and various fresh filleted finfish imported from [redacted]
2. 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 frozen Cooked Shrimp shipped direct to you from [redacted] and for fresh, wild, Perch fillets from [redacted]. In addition, various other fresh finfish fillets from [redacted] lacked an affirmative step.
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," seizing your adulterated product(s) and/or enjoining your firm from further violating the Act.
You should respond in writing within 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 reply to the Food and Drug Administration, Attention: Paul A. Boehmer, Compliance Officer, 550 West Jackson Blvd., Floor 15, Chicago, IL 60661. If you have questions regarding any issues in this letter, please contact Consumer Safety Officer Darrell
Luedtke, at (847) 249-8632 extension 106.
Scott J. MacIntire
Enclosure: cy FDA 483