| 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
October 15, 2010
W/L 06-11
Mr. Rex N. Ito, President
Prime Time Seafood, Inc.
1515 E. 20th Street
Los Angeles, CA, 90011
Dear Mr. Ito:
We inspected your seafood processing and importer establishment, located at 1515 E. 20th Street, Los Angeles, CA, 90011 on June 22-29, 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 (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 CPR 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 tuna and wahoo 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 were as follows:
1. 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 histamine species fish lists monitoring procedures and frequencies of (b)(4) at the storage critical control point. These procedures and frequencies are not adequate to control histamine formation. FDA recommends continuous monitoring of refrigeration temperatures; or to check at least twice per day the condition of ice surrounding product to control histamine formation.
2. You must have a HACCP Plan that, at a minimum, lists the critical limits that must be met to comply with 123 CFR 123.6 (c)(3). A critical limit is defined in 21 CFR 123.3(c) as the "maximum or minimum value to which a physical, biological or chemical parameter must be controlled at a critical control to prevent, eliminate or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm's HACCP plan for histamine species fish, lists a critical limit of (b)(4) at the receiving critical control point that is not adequate to control at the receiving critical control point that is not adequate to control histamine formation. For fish that are held under ice or chemical cooling media, FDA recommends checking for the adequacy office or chemical cooling media at receiving.
3. Since you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for your histamine species at the storage critical control point is not appropriate. Specifically, your corrective action (b)(4) can not implemented because your firm is monitoring the presence of ice (b)(4) per day and monitoring storage temperatures only (b)(4) . Consequently, you will not have time and temperature parameters that will be based on four hour intervals.
4. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring procedures of (b)(4) at the receiving critical control point; and check (b)(4) at the storage critical control point to control histamine formation as listed in your HACCP plan for histamine species fish. In addition, we note that your firm is taking multiple internal temperatures of the incoming fish, but your "Lot Grading Worksheet" which is the record for these temperature measurements only has space for one single temperature measurement. Please be advised that all temperature measurements that are taken should be recorded.
5. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor (1) condition and cleanliness of food contact surfaces; (2) prevention of cross contamination from insanitary objects to food with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
a. rough surface with gouges and accumulation of organic residue on cutting board used to process ready to eat, sashimi grade yellowfin tuna.
b. use of a hose that had been in direct contact with the floor and the rim of a trash can to wash ready to eat, sashimi grade yellowfin tuna.
c. not using detergent during cleaning conducted prior to sanitizing food contact surfaces such as cutting boards.
Deficiencies regarding various aspects of the HACCP requirements for imported items include the following:
1. Your written verification procedures must list, at a minimum, product specifications that are designed to ensure that the fish and fishery products you import are not adulterated under section 402 of the Act because they may be injurious to health or have been processed under insanitary conditions, to comply with 21 CFR 123.12(a)(2)(i). However, your firm could not provide product specifications for fresh wahoo that you imported from Ecuador on or about June 8, 2010.
2. In addition, 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 bluefin tuna that you have imported from (b)(4) , in Turkey, on or about October 28th, 2009.
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.
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:
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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