Inspections, Compliance, Enforcement, and Criminal Investigations
Meyer Food Service LLC dba Empire Fish Co 1/25/10
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Minneapolis District Office
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7194
FAX: (612) 334-4142
January 25, 2010
RETURN RECEIPT REQUESTED
Refer to MIN 10 - 09
Stephen C. Meyer
Owner and President
Meyer Food Service LLC dba Empire Fish Co
11200 W. Watertown Plank Road
Wauwatosa, Wisconsin 53226-3411
Dear Mr. Meyer:
We inspected your seafood processing facility located at 11200 W. Watertown Plank Road, Wauwatosa, WI, 53226 on October 1-7, 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 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 vacuum-packed cold-smoked salmon, bonito, mahi-mahi, tuna, wahoo, mackerel, jobfish, jack or crevalle, trevally, escolar, clams, cockles, mussels, oysters, scallops, and air packed, hot-smoked salmon 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 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 produce 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). However, your firm does not have a HACCP plan for vacuum-packed cold-smoked salmon to control the food safety hazards of Clostridium botulinum growth and toxin formation.
2. 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).
• In addition, your firm's HACCP plans for clams, cockles, mussels, oysters, scallops list monitoring frequencies at the "Refrigerate"
critical control point that are inadequate to control pathogen growth. Specifically, your plan lists that you will monitor cooler temperature (b)(4) is not addressed. As discussed above, this frequency does not provide adequate time/temperature data to assess time/temperature fluctuations that would allow you to detect extensive deviations from your critical temperature limit of (b)(4)degrees Fahrenheit ((b)(4)F) or less. Again, we recommend the use of monitoring equipment capable of monitoring and recording time and temperature on a 24 hour a day/7 day a week basis, with a daily check of the record and a daily check of the equipment to ensure temperatures do not rise above (b)(4)F for extended periods of time without your knowledge.
• However, your firm's HACCP plans for air-packed, hot-smoked fish list monitoring frequencies at the "Refrigerate" critical control point that are inadequate to control pathogen growth and toxin formation in that your plan requires you to monitor cooler temperature (b)(4) is not addressed. This frequency does not allow you to meet your critical limit of maintaining your cooler at (b)(4) degrees Fahrenheit ((b)(4)F) or less, as the time span between monitoring may allow the temperature to rise above (b)(4)F for extended periods of time without your knowledge.
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.
For your information, pasteurized canned crab meat has the hazard of Clostridium botulinum growth and toxin formation.
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 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 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.
Please send your reply to the Food and Drug Administration, Attention Rebecca L. Caulfield, Compliance Officer, at the address on this letterhead. If you have questions regarding any issues in this letter, please contact Ms. Caulfield at (612) 758-7194.
W. Charles Becoat