Source: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2003/ucm147629.htm
Timestamp: 2013-06-19 13:41:19
Document Index: 75438540

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

Ice Cold Staorage 31-Jul-03 Quick Links: Skip to main page content
Ice Cold Staorage 31-Jul-03
Public Health Service Food and Drug Administration San Francisco District
Telephone: 510/337-6700 VIA FEDERAL EXPRESS
Our Reference: FEI 3003726730
Ice Cold Storage of Nevada, LLC
July 31, 2003 Martin J. Evanson, Chief Executive Officer Ice Cold Storage 3336 Fruitland Avenue Vernon, California 90058 WARNING LETTER
Dear Mr. Evanson: On June 5, 2003, we inspected your seafood facility, Ice Cold Storage of Nevada, LLC, located at 3854-A Civic Center Drive, North Las Vegas,Nevada 89030. We found that you have serious deviations from the seafood HACCP regulations in Title 21, Code of Federal Regulations, part 123 (2I CFR Part 123). In accordance with 21 C.F.R. § 123.6(g), failure of a processor to have and implement a HACCP plan that complies with this section, or otherwise operate in accordance with the requirements of this part, renders the fish and 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, histamine forming fish, e.g., [redacted] and [redacted] your refrigerated, ready-to-eat, vacuum packaged fish and fishery products, e.g., [redacted] and [redacted] are adulterated, in that the products have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act and the seafood HACCP regulations through links in FDA's home page at www.fda.gov.. The attached handout explains how you can obtain a copy of the Fish & Fisheries Products Hazards & Controls Guidance, 3rd edition, June 2001. We listed the deviations on a Form FDA 483 and discussed them with James J. Anderson, General Manager, at the conclusion of the inspection. We are enclosing a copy of the FDA 483 for your reference. Your serious HACCP deviations were: You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and you must have a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR. § 123.6(s) and (b). (a) However, your firm does not have a HACCP plan for refrigerated, histamine forming fish, such as, [redacted] and [redacted] to control the food safety hazard of histamine formation as a result of time/temperature abuse.
(b) However, your firm does not have a HACCP plan for refrigerated, ready-to-eat, vacuum packaged fish and fishery products, such as, [redacted] and [redacted], to control pathogen growth and toxin formation, including Clostridium botulinuin toxin formation. You must immediately take appropriate steps to correct the violation at your facility. We may initiate regulatory action without further notice if you do not correct the problem. For instance, we may take further action to seize your products or enjoin your firm from operating. Please respond in writing within fifteen (15) working days of receipt of this letter. Your response should outline the specific things that you are doing to correct the deviations. You may wish to include in your response documentation, such as, copies of your HACCP plans, temperature
monitoring records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all of the corrections before you respond, we expect that you will explain the reason for your delay, and state when you will correct any remaining deviations. This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulations and the Good Manufacturing Practice regulations (21 C.F.R. § 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. Your response should be directed to: Ms. Erlinda N. Figueroa, Compliance Officer, U.S. Food and Drug Administration, 1431 Harbor Bay Parkway,Alameda, CA 94502-7070. If you have any questions regarding any issue in this letter, please contact Ms. Figucroa at (510) 337-t5795. Sincerely, /s/
District Director San Francisco District Enclosures: Form FDA 483 Handout on Fish & Fisheries Products Hazards & Controls Guidance, 3rd edition, June 2001 cc: VIA Federal Express James J. Anderson, General Manager Ice Cold Storage, LLC 3840-A Civic Center Drive North Las Vegas, Nevada 89030. -