Inspections, Compliance, Enforcement, and Criminal Investigations
Andersen America, Inc.10/22/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Francisco District
UPS OVERNIGHT DELIVERY
October 22, 2012
Our Reference # 3000207318
Mr. Nobumitsu Kobayashi, President
Andersen America, Inc.
30703 San Clemente Street
Hayward, CA 94544
Dear Mr. Kobayashi:
We inspected your seafood processing facility located at 30703 San Clemente Street, Hayward, California, between the following dates: June 19 to June 29, 2012. 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, vacuum-packaged tuna salad products 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 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 your ready-to-eat, vacuum-packaged tuna salad product to control the food safety hazards of histamine formation and Clostridium botulinun toxin formation. Although you primarily ship the ready-to-eat, vacuum-packaged tuna salad to your own retail outlets, our investigators also documented that you ship the tuna salad to a wholesale customer. As such, you will need to have and implement a HACCP plan for this product.
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 does not maintain sanitation monitoring records for safety of water; conditions and cleanliness of food contact surfaces; prevention of cross contamination; maintenance of hand-washing, hand-sanitizing and toilet facilities; protection from adulterants; proper labeling, storage and use of toxic compounds; employee health conditions and exclusion of pests required for the processing of ready-to-eat, vacuum-packaged tuna salad.
The above violations are not intended to be an all-inclusive list of violations at your firm.
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) 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 sanitation monitoring 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.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-1(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please send your reply to Lawton W. Lum, Director of Compliance at 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have questions regarding any issues in this letter, please contact Brandon L. Bridgman, Compliance Officer, at (510) 337-6794.
Barbara J. Cassens
San Francisco District
U.S. Food and Drug Administration