| 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 Services
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
July 19th, 2011
W/L 47-11
Masahide Yamamoto, President
Yamaya USA Inc.
3420 Kashiwa St.
Torrance, CA 90505-4025
Dear Mr. Yamamoto:
We inspected your seafood processing and importer establishment, located at 3420 Kashiwa St, Torrance, CA on April 7-13, 2011. 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 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).
Accordingly, your Capelin Roe and Pollack Roe 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.
The significant violations documented during the inspection include the following:
1. Because you chose to include a corrective action plan in your HACCP plans, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for frozen Pollack Roe and frozen Capelin Roe at the numerous critical control points to control pathogen growth. Specifically,
• Your frozen Pollack Roe HACCP plan lists corrective actions at the thawing, coloring, seasoning, draining, and labeling CCPs that do not ensure that the cause of the deviation is corrected.
• Your frozen Capelin Roe HACCP plan lists corrective actions at the thawing, coloring and seasoning CCPs that do not ensure that the cause of the deviation is corrected.
2. You must implement affirmative steps that 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 affirmative steps for Capelin Roe your firm imported from (b)(4) Your firm did not perform affirmative steps for Pollack Roe your firm imported (b)(4)
We have received your written response to the inspection, dated April 21, 2011 and received on April 27, 2011. In your response you state that you:
1. have amended your critical limits from (b)(4) in both HACCP plans to prevent pathogen growth.
2. have amended your plans to maintain the product temperatures under (b)(4) during thawing, coloring and draining of the salted and salted/seasoned products and intend to set your refrigerator temperatures at (b)(4) to ensure proper storage temperatures are maintained during any extended storage periods such as during (b)(4)
3. have added the hazard of undeclared allergens to your Capelin Roe HACCP plan, and intend to monitor and record for the presence of allergenic substances in the ingredient statements.
4. have ordered two recording thermometers for use in process rooms.
While the descriptions provided in your response appear to address the concerns noted during the inspection, your firm did not provide any supporting documentation to verify the corrections for these concerns. For example, your firm did not provide a copy of the revised HACCP plans for these products, or any records to demonstrate that the new plans have been implemented, or any information related to installation of the recording thermometers.
Again, please be advised that management of the cumulative time and temperature of exposure above 40°F throughout processing is important to producing a safe product, especially for ready to eat products such as yours where there are multiple processing steps exposing the products to varied temperatures above 40°F, and where there will not be a cook step prior to consumption. Controls should be included in your HACCP plan when necessary. We suggest you refer to Chapter 12 of the 4th Edition of the Hazard Guide for information regarding the time and temperature controls necessary for your products, based on the multiple steps that occur during processing.
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," and/or seize your product(s) and/or enjoin your firm from further violating the Act.
The above violations are not intended to be an all-inclusive list of violations in your plant. Other violations can subject your food products to legal action. It is your responsibility to ensure that all of your products are in compliance with all requirements of the Act and federal regulations.
We request that you notify this office in writing within 15 working days from your receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, include documentation of your corrective actions or steps towards long term, corrective action, such as HACCP and importer verification records, records that document the performance and results of your firm's affirmative steps, HACCP plans, monitoring and verification records associated with your activities as a domestic processor, and any 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 please include a timetable for the implementation of any remaining corrections.
Please send your reply to the Food and Drug Administration, Attention:
Blake Bevill
Director Compliance Branch
Los Angeles District
19701 Fairchild
Irvine, CA, 92612-2506
If you have questions regarding any issues in this letter, please contact David Whitman, Compliance Officer at 858-550-3850 x106.
Sincerely,
/S/
Alonza E. Cruse
District Director
Los Angeles District
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