Inspections, Compliance, Enforcement, and Criminal Investigations
Willharvdoit Corporation 17-Oct-05
Department of Health and Human Services
Public Health Service
Minneapolis District Office
October 17, 2005
RETURN RECEIPT REQUESTED
William P. Harvey
4706 West State Street
Milwaukee, WI 53208-3144
Dear Mr. Harvey:
We inspected your seafood processing facility, located at 4706 West State Street, Milwaukee, Wisconsin, on September 15, 16, 19 and 20, 2005. 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 Tuna Salad Sandwich is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards 8s Controls Guidance through links in FDA's home page at www.fda.gov.
Your most significant violations were as follows:
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 Tuna Salad Sandwich to control the food safety hazard of pathogen growth and toxin formation.
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 condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments; and the prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves; and outer garments, and from raw product to cooked product with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR 110 as evidenced by:
Employee practices in glove maintenance as demonstrated by an employee using the rim of a trash can to wipe sauce off their glove and returning to production without changing gloves; an employee touching trash can and underside of production table while handling ready-to-eat sandwich products without changing gloves; and an employee wiping a scraper on their apron after removing it from a sanitizer pail and proceeding to use it for production.
Employee practices in sanitary production as demonstrated by an employee placing an unlined bread tray on top of a trash can containing wrapped finished product and the tray is subsequently moved to a production table; and packaging materials stored on the bottom shelf of tables in the production room were uncovered and observed with a buildup of debris from production.
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 fifteen (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 the Food and Drug Administration, Attention: Tyra S. Wisecup, Compliance Officer. If you have questions regarding any issues in this letter, please contact Ms. Wisecup at (612) 758-7114.
W. Charles Becoat