Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/central-boeki-california-ltd-09082015
Timestamp: 2020-08-13 15:53:47
Document Index: 675340297

Matched Legal Cases: ['art 123', 'art 123', 'art 110', 'art 110', 'art 123', '§ 342', 'art 123']

Central Boeki California Ltd - 09/08/2015 | FDA
Central Boeki California Ltd - 09/08/2015
Central Boeki California Ltd September 08, 2015
WL# 34-15
Mr. Hitoshi Endo, Executive Vice President
Central Boeki California, Ltd.
19801 Rancho Way, Suite A
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).
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.
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)].