Inspections, Compliance, Enforcement, and Criminal Investigations
Bodin's, Inc. 19-Jun-07
Department of Health and Human Services
Public Health Service
Minneapolis District Office
June 19, 2007
RETURN RECEIPT REQUESTED
Refer to MIN 07-17
Beta Bodin Damberg
208 Wilson Avenue
Bayfield, Wisconsin 54814
Dear Ms. Damberg:
We inspected your seafood processing facility located at 208 Wilson Avenue on April 24 - 27, 2007. 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 & 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 smoked fish 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 in FDA's home page at www.fda.gov.
Your most significant violations were as follows:
You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor prevention of cross-contamination from insanitary objects with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidence by the observation made by our investigator of an employee handling cooked product after the same employee had handled raw product wearing the same clothing. This practice allows pathogens that may be present on the raw product to be transferred to the cooked product. For example, Listeria monocytogenes is a pathogen that is found on raw finfish, is easily transferred to cooked product through mishandling and can grow at refrigeration temperature.
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.
We note that you corrected the monitoring critical limit at the storage critical control point in your HACCP plan for hot-smoked whitefish and lake-trout to provide for continuous monitoring. Your firm also indicated that a monitoring device suitable for that task was ordered. Please provide us with a copy of 14 consecutive days' worth of cooler monitoring records.
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 the continuous cooler monitoring records and sanitation monitoring 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 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.
Please send your reply to the Food and Drug Administration, Attention: Tyra S. Wisecup, Compliance Officer, at the address in the letterhead. If you have questions regarding any issues in this letter, please contact Ms. Wisecup at (612) 758-7114.
W. Charles Becoat