Wing Kee Foodstuff Co. 8/13/12
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||San Francisco District|
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
August 13, 2012
Mr. Ping Lau Kwan
Wing Kee Foodstuff Company
1251 Stockton Street
San Francisco, California 94133
Dear Mr. Kwan:
The Food and Drug Administration (FDA) conducted an inspection of your facilities located at 1036 Quesada Ave and 1016 Revere Ave, San Francisco, California on June 18 – June 21, 2011. We found that you have a serious violation of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). The specific requirements for imported fish and fishery products are set out in 21 CFR 123.12. As an importer of fish or fishery products, you must operate in accordance with the requirements of Part 123. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), and will be denied entry. Because our inspection identified serious violations for 21 CFR Part 123, your dried conch slices, dried whole eviscerated pollock, and dried shrimp imported from Hong Kong are adulterated under Section 402(a)(4)of the Act, 21 U.S.C. § 342(a)(4), 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:
- You must implement an affirmative step designed to ensure that the fish and fishery products that you import into the United States were processed in accordance with the requirements of FDA's seafood HACCP regulations, to comply with 21 CFR 123.12(a)(2)(ii). However, your firm did not implement an affirmative step for the following products:
- Dried conch slices that you imported on May 7, 2012 (U.S. Customs entry number (b)(4), from (b)(4).
- Dried flatfish that you imported on May 7, 2012 (U.S. Customs entry number (b)(4), from (b)(4).
- Dried cuttlefish that you imported on May 7, 2012 (U.S. Customs entry number (b)(4), from (b)(4).
- Dried whole eviscerated pollock that you imported on December 28, 2011 (U.S. Customs entry number (b)(4), from (b)(4).
- Dried shrimp that you imported on December 28, 2011 (U.S. Customs entry number (b)(4), from (b)(4).
- Dried octopus that you imported on December 28, 2011 (U.S. Customs entry number (b)(4), from (b)(4).
- Dried oyster that you imported on December 28, 2011 (U.S. Customs entry number (b)(4), from (b)(4).
For additional information and guidance, please refer to the Fish and Fisheries Products Hazards and Controls Guidance: 4th Edition (the Hazard Guide) through links in FDA's home page at www.fda.gov
We may take further action if you do not promptly correct this violation. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act, 21 U.S.C. § 381(a), including placing them on "detention without physical examination," seize your product(s) and/or enjoin your firm from further violating the Act.
We acknowledge your verbal responses on June 21, 2012 to the violations noted in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection. The adequacy of your firm’s responses cannot be determined at this time. Your response promised to correct the violations noted above with no specific timeframe. As of August 8, 2012, we have received no further response from your firm. We will verify the adequacy of your corrective actions during the next inspection of your firm.
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 and the seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for the fish or fishery products that you import into the United States.
Your written response should be directed to:
Lawton W. Lum
Director of Compliance
1431 Harbor Bay Parkway
Alameda, California 94502
Refer to the Unique Identification Number (CMS 336438) when replying.
If you have any questions about the content of this letter please contact Ms. Aleta T. Flores, Compliance Officer at (510) 337-6821.
Barbara J. Cassens