Inspections, Compliance, Enforcement, and Criminal Investigations
Basic American Foods 10/7/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
October 7, 2009
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 10-01
Loren Kimura, President
Basic American Foods
dba Harris Soup Company
2121 North California Boulevard, Suite 400
Walnut Creek, California 97230
Dear Mr. Kimura
We inspected your seafood processing facility, located at 17711 NE Riverside Parkway, Portland, Oregon, on June 23-24, 2009. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations, Title 21, Code of Federal Regulations (CFR), Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, CFR, Part 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 refrigerated, ready-to-eat soups/chowders 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 significant violations are 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 have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm's HACCP plan for your refrigerated "Fully Cooked - not shelf stable, Ready-to-Serve Soups & Chowders," does not list the food safety of Clostridium botulinum. The specifications for your packaging material used for the twenty-four ounce and eleven ounce container for ready-to-serve soups and chowders are the same as previously reviewed by the agency. These materials create an anaerobic environment conducive to Clostridium botulinum growth and toxin formation. As such, we advise you that your products will need a secondary barrier in addition to refrigeration to control Clostridium botulinum growth and toxin formation.
However, there appears to be no supporting evidence or information to substantiate that the finished soup products do not pose a hazard for growth and subsequent toxin formation. Consequently, in the absence of data and information to suggest otherwise, we would expect your firm to develop adequate controls in your plan to address this specific pathogen. For example, we suggest that your firm amend your temperature critical limit at the "Refrigerated Finished Goods Storage" critical control point to list <38°F, rather than (b)(4)F and utilize a temperature monitor, such as a time/temperature indicator (TTl) on each package.
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.
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 importer verification records and records, that document the performance and results of your firm's affirmative steps, 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 seafood importer establishment 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: Lisa M. Elrand, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issues in this letter, please contact her at 425-483-4913.
Charles M. Breen