Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Los Angeles District |
Irvine, CA 92612-2506
VIA UNITED PARCEL SERVICE
September 8, 2015
Mr. Hitoshi Endo, Executive Vice President
Central Boeki California, Ltd.
19801 Rancho Way, Suite A
Rancho Dominguez, CA, 90220
Dear Mr. Endo:
We inspected your seafood processing and importer establishment, located at 19801 Rancho Way, Suite A, Rancho Dominguez, CA, 90220, from June 12-15, 2015. 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 Part 123), and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (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 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).
As an importer of fish or fishery products, you must operate in accordance with the requirements of 21 CFR 123.12. 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 Part123. If assurances do not exist that the imported fish or fishery products have been processed under conditions 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 Act, 21 U.S.C. §342(a)(4).
Accordingly, your refrigerated Baked Sardines, Baked Goby and Fish Sausage and frozen Jack Mackerel 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.
We received your response letter on July 7, 2015 concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. We address your response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
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 Baked Sardines, refrigerated Baked Goby, and refrigerated Fish Sausage to control the food safety hazards of pathogen growth and toxin formation. In addition, our inspection found Baked Sardines and Baked Goby, labeled as “KEEP REFRIGERATED”, were being stored in your ambient temperature warehouse.
The adequacy of your response cannot be determined at this time. Your response included a new HACCP plan for refrigerated, ready to eat, vacuum packed seafood products. However, you did not include any documentation demonstrating that employees have been trained on the new procedures, nor did you provide CCP monitoring records demonstrating the HACCP plan has been implemented.
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 maintenance of hand washing, hand sanitizing, and toilet facilities; protection of food, food packaging materials, and food contact surfaces from adulteration; proper labeling, storage and use of toxic chemicals; and exclusion of pests, required for the processing (holding) of your refrigerated Baked Sardines, Baked Goby and Fish Sausage, and frozen Jack Mackerel.
The adequacy of your response cannot be determined at this time. Your response included a new Sanitation Standard Operating Procedure (SSOP). However, you did not include any documentation that employees have been trained on the new sanitation monitoring procedures nor did you provide recent sanitation monitoring records demonstrating implementation.
3. You do not have or have not implemented written verification procedures, product specifications and an affirmative step for ensuring that fish you import are processed in compliance with the Seafood HACCP regulation, as required by 21 CFR 123.12(a)(2). Specifically, you do not have the subject documentation for (b)(4) brand Fish Sausage, manufactured by (b)(4) Japan, that you imported on March 7, 2015.
We reviewed your firm’s response and conclude that it is not adequate. Your response included a document titled “HACCP Verification Plan” that will reportedly be used to assess foreign suppliers HACCP plans. However, you have not included product specifications for the fish sausage product, nor have you included documentation of an affirmative step for the foreign manufacturing firm.
We may take further action if you do not promptly correct these violations. 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.
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, records that document the performance and results of your firm’s affirmative steps, HACCP and verification records associated with your activities as a domestic processor, 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.
Please be advised “Processing” means, with respect to fish or fishery products: Handling, storing, preparing, heading, eviscerating, shucking, freezing, changing into different market forms, manufacturing, preserving, packing, labeling, dockside unloading, or holding [21 CFR Part 123.3(k)(1)].
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) 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 for your fish or fishery products, including those that you import into the United States.
Please send your reply to the Food and Drug Administration, Attention:
CAPT Dan Cline, Acting Director
Los Angeles District
Irvine, CA, 92612-2506
Foods: 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-31(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.
If you have questions regarding any issues in this letter, please contact David Whitman, Compliance Officer at (619)-941-3769.
Alonza E. Cruse, Director
Los Angeles District
David M. Mazzera, Ph.D.
Chief, Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue, MS-7602
Sacramento, California 95899-7413