Inspections, Compliance, Enforcement, and Criminal Investigations
At Last Gourmet Foods 28-Jul-06
Department of Health and Human Services
Public Health Service
July 28, 2006
Refer to MIN 06-31
RETURN RECEIPT REQUESTED
At Last! Gourmet Foods
2101 East 24th Street
Minneapolis, MN 55404-4111
Dear Ms. Barnes:
We inspected your seafood processing facility, located at 2101 East 24th Street, Minneapolis, MN, on June 7-8, 2006. 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, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 and 110). 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 soups with seafood are adulterated 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 violations are as follows:
You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and you must have 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). However your firm does not have a HACCP plan for soups with seafood identified as Lobster Bisque, Lobster Bisque with Crab Meat, and Gumbo with shrimp, and New England Clam Chowder, to control the food safety hazards of microbiological contamination.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
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 verification records, 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 processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR 123) and the Current Good Manufacturing Practice regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Jane Nelson, Compliance Officer, 212 Third Avenue South, Minneapolis, Minnesota 55401. If you have questions regarding any issues in this letter, please contact Ms. Nelson at (612) 758-7119.
W. Charles Becoat