Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Los Angeles District|
Irvine, CA 92612-2506
VIA UNITED PARCEL SERVICE
April 19, 2013
Alain Cohen, Owner
Kosher Foods Unlimited, Inc.
1410 Livonia Avenue
Los Angeles, CA 90035-3318
Dear Mr. Cohen:
We inspected your seafood processing facility located 1410 Livonia Avenue, Los Angeles, CA between the following dates: February 11-14, 2013. 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 123). 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 ready-to-eat tuna salad products, including tuna salad sandwiches and other tuna salad products, which are manufactured with scombrotoxin-forming finfish tuna, 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 acknowledge the receipt of your written response letter dated February 27, 2013. The agency has reviewed your response, and we continue to have concerns because you have not provided any detailed evidence or documentation of corrections.
Your significant violations are 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 have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6 (a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3 (f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm’s HACCP plan for refrigerated Ready-to-Eat Products including tuna salad products does not list the following food safety hazards:
a. Undeclared allergens. FDA has identified allergens as a food safety hazard and must be included in your HACCP plan.
b. Histamine formation. FDA has identified possible histamine formation in your exposed tuna salad during the (b)(4) steps in your process flow.
Please refer to Chapter 19 (Undeclared Major Food Allergens) and Chapter 7 (Scombrotoxin (Histamine) Formation) of the Fish and Fishery Products Hazards and Controls Guidance: Fourth Edition for guidance in determining the appropriate controls for your processing operations.
You explain in your February 27, 2013, response you were adding the hazard of undeclared allergens into your HACCP plan. However, you did not provide a copy of your revised HACCP plan. Please provide this plan for our review, taking into consideration both unidentified hazards listed above.
2. You must implement the monitoring procedures that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm did not follow the monitoring procedure of (b)(4) tuna salad product to be (b)(4) every (b)(4) at the “(b)(4)” critical control point (CCP (b)(4)) to control “(b)(4)” listed in your HACCP plan for Ready-to Eat Products.
Your response does not address this violation. If you have started monitoring this critical control point (CCP) as you indicated in your close-out discussion with the Investigator on February 14, 2013, please provide representative copies of these monitoring records for our review.
3. 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 any of the eight key sanitation conditions and practices required for the processing of tuna salad products.
Your response does not adequately address this violation, and does not specifically reference this violation and/or correction. If your company has created sanitation monitoring documents and you are monitoring the key sanitation practices and conditions necessary for your tuna salad processing operations, please provide some recent examples of these records.
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 firm from operating.
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.
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 copies of any revised HACCP plans, at least five (5) product days worth of HACCP monitoring records to demonstrate that you have implemented the revised plans, any verification records, and 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 processing plant operates in compliance with the Act, 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.
Your response should be sent to:
Mr. Blake Bevill
Director, Compliance Branch
U.S. Food and Drug Administration
Los Angeles District
19701 Fairchild Road
Irvine, CA 92612-2506
If you have any questions regarding any issue in this letter, please contact Robert McNab, Compliance Officer at (949) 608-4409. Please include the ID 3005868572 in all correspondence.
Alonza E. Cruse, Director
Los Angeles District
Hugo Cornejo, Acting Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue MS 7602
PO Box 997435
Sacramento, CA 95899-7435
Attn: FDA Correspondence