Inspections, Compliance, Enforcement, and Criminal Investigations
Aramark Healthcare Albany Production Center 9/12/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|158-15 Liberty Avenue|
Jamaica, New York 11433-1034
September 12, 2011
Warning Letter NYK-2011-35
Joseph Nuebauer, CEO
1101 Market Street
Philadelphia, PA 19107
Dear Mr. Nuebauer:
We inspected your seafood processing facility, located at 10 Burdick Dr, Albany, New York on June 1 through June 6, 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, 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). Accordingly, your ready-to eat Tuna Salad, Nantucket Baked Fish, and Manhattan Clam Chowder 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 violation was as follows:
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 the following products:
o Ready-to eat Tuna Salad to control the food safety hazards of scombrotoxin formation (histamine) and pathogen growth and toxin formation including Clostridium botulinum due to time/temperature abuse.
o Nantucket Baked Fish (breaded cod) to control the food safety hazards of pathogen growth, pathogen survival through cooking or pasteurization and toxin formation including Clostridium botulinum due to time/temperature abuse.
o Manhattan Clam Chowder to control the food safety hazards of pathogen growth, pathogen survival through cooking or pasteurization and toxin formation including Clostridium botulinum due to time/temperature abuse.
We acknowledge your letter of response dated June 24, 2011. However, there was no information or documentation provided in the response on which to make any assessment concerning corrections to the observations of concern noted during the inspection. For more information please refer to Chapters 2 and 3 of the Fish and Fishery Products Hazards and Controls Guidance.
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 in violation of Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4) and the seafood HAACP regulation. We may also take further action to enjoin your firm from operating in violation of Section 415 of the Act (21 U.S.C. § 350d) and 21 CFR Part 1, Subpart H.
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 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), and is registered in accordance with the Food Facility Registration regulation (21 CFR Part 1, Subpart H). 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: LCDR Kristen C. Jackson, Compliance Officer, U.S. Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, New York 11433. If you have questions regarding any issues in this letter, please contact LCDR Jackson at (718) 662-5711.
Ronald M. Pace
New York District