Inspections, Compliance, Enforcement, and Criminal Investigations
United Fish Distributors, Inc. 11/19/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
300 River Place
Detroit, MI 48207
November 19, 2009
VIA FEDERAL EXPRESS
Keith B. Davis, President
United Fish Distributors, Inc.
1349 Adelaide Street
Detroit, Michigan 48207-2653
Dear Mr. Davis:
We inspected your seafood processing facility, located at 1349 Adelaide Street, Detroit, Michigan 48207-2653 on July 15 - 27, 2009. 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), and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 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 various fish and fishery products, including your Pasteurized Canned Crabmeat are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or 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 have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plan, "SEAFOOD SUBJECT TO CLOSTRIDIUM BOTULISM" (dated 5/4/2009), lists a monitoring procedure at the receiving critical control point that is not adequate to control the hazard of Clostridium botulinum growth and toxin formation when products are expected to be in transit for extended time periods. Because your firm routinely receives Pasteurized Canned Crabmeat from a supplier in (b)(4) Maryland, FDA recommends that transportation conditions for your refrigerated crabmeat in oxygen limiting containers be monitored continuously throughout transport either through time/temperature data loggers to ensure that the products remained at or below 40°F for the entire transit period; or, when received on ice that you check for the adequacy of ice at receipt.
2. You must monitor sanitation conditions and practices during processing, with sufficient frequency to ensure, at a minimum, compliance with current good manufacturing practice requirements in 21 CFR 110, to comply with 21 CFR 123.11(b).
a. Your firm did not monitor with sufficient frequency protection of food, food packaging material, and food contact surfaces from adulteration [21 CFR 123.11(b)(5)], as evidenced by:
• Lights, which are not of safety-type construction, were observed throughout the facility. For example:
• A fluorescent tube-type light with green end caps was suspended not more than 79 inches directly above the cutting board surface on which pin boning of Whitefish was observed.
• An unprotected light bulb was observed to be less than 68 inches from ice, later used to pack Whitefish, Bronzini (Sea Bass) and Buffalo Fish.
• Four (4) lights in Freezer #1 were observed to be unprotected.
• Not less than four (4) panels of the drop ceiling, measuring approximately 1' x 2' each, were observed to be missing from the ceiling in the walk-in cooler. The exposed surface was observed to be deteriorated with a dark brownish-black crumbling and uneven surface. Salmon and other fish were observed to be exposed beneath this ceiling.
b. Your sanitation monitoring records document that cleaning compounds and lubricants were labeled and stored properly, 21 CFR 123.11(b)(6). However, the following was observed:
• A red, unlabeled oil can was observed in the processing room above the pin boning table during processing of Whitefish.
• A White, unlabeled bucket containing a blue-colored liquid was observed in the processing room during the processing of Whitefish fillets.
• A white, unlabeled bucket containing a pink-tinted liquid was observed in the processing room during the processing of Whitefish fillets. Cloth gloves were
observed to be soaking in this bucket.
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) 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. This letter may not list all the violations at your facility. You are responsible for ensuring that your seafood establishment operates in compliance with the Act and the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice 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.
Please send your written reply to LCDR Anastasia M. Piliafas-Brown, Compliance Officer at the address on this letterhead. If you have any questions about the content of this letter, please contact LCDR Piliafas-Brown at (313) 393-8270.
Joann M. Givens
Cc: Michigan Department of Agriculture
Food and Dairy Division
Attention: Katherine Fedder
PO BOX 30017
Lansing, MI 48909