Inspections, Compliance, Enforcement, and Criminal Investigations
Mrs. Williams Country Kitchen Inc. 22-May-06
Department of Health and Human Services
Public Health Service
Los Angeles District
RETURN RECEIPT REQUESTED
May 22, 2006
Bradley M. Williams, Co-owner
Mrs. Williams Country Kitchen Inc.
749 Lakefield Road, Unit H
Westiake Village, CA 91361
Dear Mr. Williams:
We inspected your seafood processing facility, located at 749 Lakefield Road, Unit H, Westlake Village, CA 91361 on March 27-31, 2006. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulations 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 refrigerated Clam Chowder and Crab Bisque soups in reduced-oxygen packaging 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 regulations, and the Fish and Fisheries Products Hazards & Controls Guidance through links in 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 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 refrigerated Clam Chowder and Crab Bisque soups in 10 lb. reduced-oxygen packaging to control the food safety hazard of Clostridium botulinum growth and toxin formation due to time/temperature abuse, proper labeling of allergenic ingredients, and natural toxins/chemical contarninants/pesticides in raw materials such as your raw molluscan shellfish. In addition, your firm does not have a HACCP plan for your refrigerated Clam Chowder and Crab Bisque soups in the 12 ounce retail containers, to control the food safety hazards of proper labeling of allergenic ingredients, and natural toxins/cheniical contaminants/pesticides in raw materials such as your raw molluscan shellfish.
We maytake 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 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.
Your written reply should be addressed to:
Pamela B. Schweikert, Director, Compliance Branch
U. S. Food and Drug Administration
Irvine, California 92612-2445
If you have questions regarding any issue in this letter, please contact Robert McNab, Compliance Officer at (949) 608-4409.
Alonza E. Cruse
CC: State of California, DHS/FDB
Department of Health Services
Food and Drug Branch
P.O. Box 997413, MS-7602
Sacramento, CA 95$99-7413