Inspections, Compliance, Enforcement, and Criminal Investigations
Bay View Packing Co 11/1/12
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) 334-4100
FAX: (612) 334-4142
November 1, 2012
RETURN RECEIPT REQUESTED
Refer to MIN 13 – 04
Reinhard M. Liebner
President and Owner
Bay View Packing Co.
1906 W. Saint Paul Avenue
Milwaukee, Wisconsin 53233-2634
Dear Mr. Liebner:
We inspected your seafood processing facility located at 1906 West St. Paul Avenue, Milwaukee, Wisconsin, on September 25, 26, and October 3, 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 Herring Party Bites in Wine Sauce, Herring Party Bites in Sour Cream and Rollmop Herring products 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 on 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 Herring Party Bites in Wine Sauce, Herring Party Bites in Sour Cream, and Rollmop Herring products to control the food safety hazards of histamine development, pathogen growth and Clostridium botulinum 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). Your firm’s current monitoring procedures for Herring Party Bites in Wine Sauce, Herring Party Bites in Sour Cream, and Rollmop Herring do not include sufficient controls as follows:
- To control the hazard of histamine and Clostridium botulinum, the temperature of the herring upon receipt should be taken to ensure the fish was not temperature abused during transit to your facility.
- To control the hazard of histamine and Clostridium botulinum, the temperature of your walk-in coolers, where your herring ingredient and finished products are stored, should be monitored frequently enough to ensure the temperature does not exceed the limits.
- To control the hazard of pathogen and Clostridium botulinum growth, the pH of the finished herring products should be monitored often enough to ensure that each batch is within the limits.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.
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.
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 costs related to re-inspection. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any costs related to re-inspection.
Please send your reply to the Food and Drug Administration, Attention: Marie A. Fadden, Compliance Officer, Minneapolis District Office. If you have questions regarding any issues in this letter, please contact Ms. Fadden at (612) 758-7172.
Michael Dutcher, DVM