| Public Health Service Food and Drug Administration |
| Los Angeles District Pacific Region 19701 Fairchild Irvine, CA 92612·2506 Telephone: 949·608·2900 FAX: 949·608·4415 |
Department of Health and Human ServicesWARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
November 3, 2010
W/L 11-11
Mr. John Ikeda, President
Showa Marine Inc.
668 S Alameda St
Los Angeles, CA 90021-1234
Dear Mr. Ikeda:
We inspected your seafood processing facility, located at 668 South Alameda Los Angeles, California on July 6, 7, 13 and 15, 2010. 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).
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 Part 123. 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).
Because our inspection identified serious violations of 21 CFR Part 123, your pasteurized crab meat and histamine forming species including yellowtail (Hamachi) fillets 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.
We acknowledge the receipt of your response to the FDA 483 dated July 22, 2010 and your HACCP plan and records you faxed to us on August 17, 2010. We address your response below, in relation to each of the noted violations.
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 vacuum packaged yellowtail fillets (Hamachi) to control the food safety hazard of Clostridium botulinum.
We acknowledge your response dated August 17, 2010 that includes a HACCP plan for "Scombroid Fish". This plan lists your refrigerated vacuum packaged Hamachi as a product covered under the plan. However, this plan does not include the potential food safety hazard associated with Clostridium botulinum growth and potential toxin formation, a reasonably likely hazard in vacuum packaged fish, particularly in fresh vacuum packaged fish. In accordance with 21 CFR 123.6(b)(2) firms may only group kinds offish and fishery products together in the same HACCP plan when the food safety hazards, critical control points, critical limits and procedures identified are identical for all the fish and fishery products so grouped or all production methods so grouped. The plan you provided does not list the hazard of Clostridium botulinum growth and toxin formation, as well as the controls necessary to prevent or reduce the likelihood for the hazard. For example, raw vacuum packaged fresh fish needs to be controlled at or below 38°F when refrigeration is the sole barrier to the growth and toxin formation of the nonproteolytic strains of Clostridium botulinum. We suggest that your firm conduct a hazard analysis on each of your products to ensure that you have adequate HACCP plans and the necessary controls for the hazards identified during each of your analyses.
Please refer to Chapter 13 of the Fish & Fisheries Products Hazards & Control Guidance, Third Edition for additional information related to Clostridium botulinum growth and toxin formation.
2. You must implement the record keeping system that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However,
a. Your firm did not record monitoring observations at the receiving critical control point of (b)(4) at the frequency of (b)(4) to control the hazard of histamine listed in your HACCP plan for "Scromboid Fish" including yellowtail (Hamachi) for the period of 7/5/10 through 6/2/09.
b. Your firm did not record monitoring observations at the storage critical control point of (b)(4) that (b)(4) at the frequency of (b)(4) to control the hazard of histamine listed in your HACCP plan for "Scromboid Fish" including yellowtail (Hamachi) for the period of 7/6/10 through 4/4/09.
3. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plan for "Non-Scombroid Fish" that includes your pasteurized ready to eat crab meat, and which was provided in your response packet dated August 17th, lists a monitoring procedure/frequency at the storage critical control point that is inadequate to control pathogen growth and toxin formation. Specifically, checking the storage temperature (b)(4) is not adequate because this (b)(4) check does not provide any information about the adequacy of the storage temperatures between the (b)(4) check. We acknowledge that your firm has an off-site alarm system, however, this is not listed in the plan and there is no information on the adequacy of this system for monitoring and recording the storage conditions. FDA recommends the use of equipment, on site, capable of continuously monitoring and recording temperatures on a 24 hour a day/7 day a week basis, with a daily check of the record and a daily check of the equipment.
4. Because you chose to include corrective action plans in your HACCP plans, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your conective action plans for your non-scombroid fish, intended to cover your ready to eat crab meat, are not adequate to control pathogen growth and toxin formation. In addition, your corrective action plans for your scombroid fish are not adequate to control histamine. Specifically,
a. for your ready to eat crab meat, the receiving critical control point lists that you will hold and evaluate the product. However, you do not list how this evaluation will prevent the distribution of potentially unsafe product and on what parameters you will base evaluating the safety of the products. For example, your firm is (b)(4) at receipt, thus you will not have information related to the length of time that the products were held above the critical limit of (b)(4). In addition, at the storage critical control point, your plan lists that you will make repairs or adjustments. However, repairing the equipment (i.e., after an equipment failure) will not prevent the distribution of potentially unsafe products. Moreover, your firm will be unable to evaluate time and temperature exposures because your firm will not have records that reflect the continuous monitoring and recording for time and temperatures.
b. for your scombroid fish, the receiving critical control point lists that you will hold and evaluate product (b)(4). However, you do not list how this evaluation will prevent the distribution of potentially unsafe product and how this evaluation will be conducted. In addition, the storage critical control point lists that you will make repairs or adjustments and "add ice as needed". However, repairing the equipment (i.e., after an equipment failure) will not prevent the distribution of potentially unsafe products. Moreover, adding ice to products that have potentially been temperature abused is not an appropriate conective action because this action also does not prevent the distribution of potentially unsafe product.
c. your conective actions do not list how you intend to correct the cause of the deviations.
5. You must implement an affirmative step which ensure that the fish and fishery products you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2)(ii). However, your firm did not perform an affirmative step for the refrigerated vacuum packed yellowtail fillets (Hamachi) manufactured by (b)(4) that was delivered to your firm by (b)(4).
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 film 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 verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all conections 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 Cunent 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.
Please send your reply to the Food and Drug Administration, Attention:
Blake Bevill
Compliance Director
Los Angeles District
19701 Fairchild
Irvine, CA 92612-2506
If you have questions regarding any issues in this letter, please contact Marco Esteves, Compliance Officer at 949-608-4439.
Sincerely,
/s/
Alonza E. Cruse
District Director
Los Angeles District
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