| Public Health Service Food and Drug Administration |
Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401 Telephone: (612) 334-4100 FAX: (612) 334-4142 |
Department of Health and Human Services
June 17, 2011
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED Refer to MIN 11 - 32
Kim R. Wall
President
Wild Foods, Inc.
dba Ma Baensch’s, Baensch Food Products Co.
1025 East Locust Street
Milwaukee, Wisconsin 53212
Dear Ms. Wall:
We inspected your seafood processing facility located at 1025 E. Locust Street, Milwaukee, Wisconsin, from February 15-April 26, 2011. 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 Marinated Herring with Sour Cream & Chives and Marinated Herring in Wine Sauce 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 and FDA’s Fish & Fisheries Products Hazards and Controls Guidance, Fourth Edition (the Guide) through links on FDA’s home page at www.fda.gov.
Your significant violations were as follows:
You must conduct or have conducted for you a hazard analysis for each fish or 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 Marinated Herring with Sour Cream & Chives and Marinated Herring in Wine Sauce to control the food safety hazards of pathogens including Clostridium botulinum and histamine. Please see Chapter 13 of the Guide to learn more about control strategies for Clostridium botulinum in refrigerated seafoods including strategies involving salt and acidification. Please see chapter 7 of the Guide to learn more about control strategies for histamine.
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, 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 Compliance Officer Melissa I. Michurski at the address on this letter. If you have questions regarding any issues in this letter, please contact Ms. Michurski at (612) 758-7185.
Sincerely,
/S/
Gerald J. Berg
Director
Minneapolis District
-
No comments:
Post a Comment