Inspections, Compliance, Enforcement, and Criminal Investigations
Southeast Asian Food Products 24-Apr-06
Department of Health and Human Services
Public Health Service
San Francisco District
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Our Reference: FEI 3005339127
April 24, 2006
Kevin T. Trieu, Owner
Southeast Asian Food Products
541 Eddy Street
San Francisco, CA 94109
Dear Mr. Trieu:
We inspected your seafood processing facility; located at 541 Eddy Street, San Francisco, California, on January 11, 24, and 27, 2006. 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 (21 CFR 123). 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, cooked, ready-to-eat, vacuum packaged fish balls and fish cakes 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 noted at your San Francisco facility and through review of the written Establishment Inspection Report (EIR), which was prepared based on current inspection 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:
Refrigerated, cooked, ready-to-eat, vacuum packaged fish balls and fish cakes, to control the food safety hazard of pathogen growth and toxin formation, specifically Clostridium botulinum toxin, as a result of time/temperature abuse.
Refrigerated, cooked, ready-to-eat, vacuum packaged fish balls and fish cakes in which king mackerel is an ingredient, to control histamine formation, and pathogen growth and toxin formation, specifically Clostridium botulinum toxin, as a result of time/temperature abuse.
2. You must maintain sanitation control records that, at a minimum, document monitoring and corrections, to comply with 21 CFR 123.11(c). However, your firm is not documenting and maintaining records of daily sanitation monitoring of the key sanitation areas to ensure control of:
Safety of water that comes into contact with food or food contact surfaces;
Condition and cleanliness of food contact surfaces;
Prevention of cross-contamination;
Maintenance of hand washing, hand sanitizing, and toilet facilities;
Protection of food, food packaging material, and food contact surfaces from adulteration;
Proper labeling, storage, and use of toxic compounds;
Control of employee health conditions; and
Exclusion of pests from the food plant.
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 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 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 U. S. Food and Drug Administration, Attention: Ms. Erlinda N. Figueroa, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, CA 94502-7070. If you have any questions regarding any issue in this letter, please contact Ms. Figueroa at (510) 337-6795.
Barbara J. Cassens
San Francisco District