Inspections, Compliance, Enforcement, and Criminal Investigations
Shin Hwa Wholesale Distributor, Inc. 14-Nov-06
Department of Health and Human Services
Public Health Service
San Francisco District
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Our Reference: FEI 3005344248
November 14, 2006
Yeon W. Choi, President .
Shin Hwa Wholesale Distributor, Inc.
1465 Crocker Avenue
Hayward, California 94544
Dear Mr. Choi:
We inspected your seafood processing facility, Shin Hwa Wholesale Distributor, Inc., located at 1465 Crocker Avenue, Hayward, California, on August 14 and 18, 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, and the Current Good Manufacturing Practice regulation 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 salted shrimp product 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 & Controls Guidance through links in FDA's home page at www.fda.gov.
Your 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 a HACCP plan for refrigerated, ready-to-eat salted shrimp to control the food safety of pathogen growth and toxin formation as a result of time/temperature abuse.
2) You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11 (c). However, your-firm did not maintain sanitation monitoring records for the protection of food from adulteration and proper labeling, storage, and use of toxic compounds from the food plant required for receiving and storing refrigerated, ready-to-eat, salted shrimp product.
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) or enjoin your firm from operating.
You should respond in writing within fifteen (15) working days of 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 Federal Food, Drug, and Cosmetic 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.
Joseph P. lser, MD, DrPH, MSc
Acting District Director
San Francisco District