Inspections, Compliance, Enforcement, and Criminal Investigations
Schwarz Fish Co. 10/16/09
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) 758-7114
FAX: (612) 334-4142
October 16, 2009
RETURN RECEIPT REQUESTED
Refer to MIN 10-02
Neil M. Schwarz
Schwarz Fish Company
3028 South Ninth Street
Sheboygan, Wisconsin 53081
Dear Mr. Schwarz:
We inspected your seafood processing facility located at 3028 South Ninth Street, Sheboygan, Wisconsin, on July 15 and 17, 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, 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 operates 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 ready-to-eat herring products, fresh shellfish, canned pasteurized crabmeat and 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:
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 HACCP plans for the following products:
a. ready-to-eat herring including bulk packed and individually hermetically sealed jars of pickled herring, cream style herring filets and herring in wine sauce to control the food safety hazards of pathogen growth and toxin formation, including the potential for Clostridium botulinum growth and toxin formation, and histamine formation;
b. raw molluscan shellfish including in-shell mussels and oysters and shucked mussels, oysters, and clams to control the food safety hazards of marine toxins, pathogens from harvest waters, and pathogen growth and toxin formation;
c. refrigerated ready-to-eat seafood products including canned pasteurized crabmeat to control the food safety hazards of pathogen growth and toxin formation, including the potential for Clostridium botulinum growth and toxin formation.
2. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not monitor the internal fish temperatures during the hot smoking process in the East Smokehouse. Our investigator observed that a probe was not placed to monitor the internal temperature of a sample fish in product smoked in the East Smokehouse.
3. You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). However, your firm did not take a corrective action to control pathogen development and growth when your process for smoking fish deviated from your critical limit at the smoking critical control point. During the inspection, we learned that your continuous temperature recording device for monitoring of the internal fish temperature during smoking for the east and west smokehouse were and have been inoperable.
4. You must monitor sanitation conditions and practices during processing to ensure compliance with 21 CFR 123.11(b) and 21 CFR 110. However, your firm did not monitor processing conditions with sufficient frequency to ensure the prevention of cross-contamination of food from insanitary surfaces:
• The ice cooler has visible rust, loose screws and un-cleanable metal surfaces;
• The use of an ice shovel with a wooden handle that cannot be adequately cleaned and sanitized;
• The presence of both live and dead flies throughout the facility, including the processing room and the smoked fish cooler.
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.
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. In your response you should include 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). 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