Inspections, Compliance, Enforcement, and Criminal Investigations
Ritter's Fish Market 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 - 05
Jeffrey S. Ritter
Ritter’s Fish Market
30891 State Highway 27
Prairie Du Chien, Wisconsin 53821
Dear Mr. Ritter:
We inspected your seafood processing facility located at 30891 State Highway 27, Prairie Du Chien, Wisconsin, on July 24 – 25, 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, 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 smoked fish (buffalo, catfish, sturgeon, and carp) and pickled fish (pickled mullets) 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 implement the record keeping system that you listed in your Smoked Fish HACCP and your Pickled Fish HACCP plans to comply with 21 CFR 123.6(b) and (c)(7).
A. Your firm did not follow the monitoring procedure of product temperature at the finished product cooler storage step to control pathogen growth and Clostridium botulinum toxin formation listed in your HACCP plan. For example, your written HACCP plan for smoked fish and your written HACCP plan for pickled fish both list the critical limit at the finished product cooler storage step of (b)(4)°F or less, with a monitoring frequency of (b)(4) for the cooler temperature monitoring. Written Records is listed as the record keeping step; however, there were no written records showing any cooler temperature checks or record review.
B. Your firm did not record monitoring observations at the pickling step critical control point to control Clostridium botulinum toxin listed in your HACCP plan for Pickled Fish. For example, your written HACCP plan for pickled fish lists a critical limit of (b)(4) pH maximum. Written Records is listed as the record keeping step; however, there were no written records for pH.
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). However, your firm’s HACCP plan for Smoked Fish and your firm’s HACCP plan for Pickled Fish each list a monitoring frequency at the finished product cooler storage step critical control point that is not adequate to control pathogen growth and Clostridium botulinum toxin formation. Specifically, a (b)(4) monitoring frequency is not sufficient to ensure compliance with the critical limit at the finished product cooler step.
3. Because you have chosen to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for your smoked fish and your pickled fish at the finished product cooler storage step to control pathogen growth is not fully appropriate in that it does not address product that has been exposed to temperature abuse.
4. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor the prevention of cross-contamination and exclusion of pests with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR 110. For example, during the inspection:
A. A white shovel used to scoop ice for the storage of the fresh fish was observed sitting directly on the floor in the processing room.
B. There were live black flies, too numerous to count, inside of the processing room and were observed landing on food contact equipment and fish that was in-process.
C. There was water coming up out of the drain in the floor in the main processing room and pooling on the floor.
D. The white food grade hose used to clean the fish was observed with the nozzle sitting directly on the floor.
E. There were pools of water and fish blood pooled in the walk-in cooler.
5. You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for: (1) the safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice; (2) condition and cleanliness of food contact surfaces including utensils, gloves, and outer garments;
(3) prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces; (4) maintenance of hand washing, hand sanitizing, and toilet facilities; (5) protection of food, food packaging material, and food contact surfaces from adulteration; (6) proper labeling, storage and use of toxic compounds; (7) control of employee health conditions; and (8) exclusion of pests; all required for the processing of smoked fish and pickled fish.
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 in violation of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4), and the seafood HAACP regulation. We may also take further action to enjoin your firm from operating in violation of section 415 of the Act, 21 U.S.C. § 350d, and 21 CFR Part 1, Subpart H.
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.
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 Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110), and is registered in accordance with the Food Facility Registration regulation (21 CFR Part 1, Subpart H). You also have the 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: Demetria L. Lueneburg, Compliance Officer, at the address on the letterhead. If you have questions regarding any issues in this letter, please contact Ms. Lueneburg at (612) 758-7210.
Michael Dutcher, DVM
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