Inspections, Compliance, Enforcement, and Criminal Investigations
Imperial Food Services, Inc. 21-Sep-07
Department of Health and Human Services
Public Health Service
September 21, 2007
RETURN RECEIPT REQUESTED
Mr. Wayne A. Wolf, President
Imperial Food Services, Inc.
740 Schneider Drive
South Elgin, IL 60177
Dear Mr. Wolf:
We inspected your seafood processing facility, located at 740 Schneider Drive, South Elgin, IL on June 11-25, 2007. 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 (RTE) seafood salads and tuna sandwiches been prepared, packed, are 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:
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 RTE tuna shell pasta salad to control the food safety hazards of pathogen growth and toxin formation and scombrotoxin (histamine) formation;
• Your firm does not have a HACCP plan for modified atmosphere packaged (MAP) tuna salad sandwiches (including finished product packages flushed with nitrogen) to control the hazards of pathogen growth and toxin formation, including Clostridium botulinum growth and toxin formation and histamine formation. For more information on control strategies for Clostridium botulinum, please refer to Chapter 12 of the Fish and Fisheries Products Hazards and Controls Guidance: 3rd Edition.
You must conduct a hazard analysis 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 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 RTE tuna salad sandwiches (i.e., that are not MAP) does not list the food safety hazard of histamine formation.
You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). However, your firm did not take a corrective action to control the food safety hazard of pathogen growth and toxin formation and histamine formation when your process for tuna salad sandwiches deviated from your critical limit at the refrigerated storage critical control point. On eleven different days, product deviated from the critical limit listed in your plan, i.e., of 40°F.
You must adequately monitor sanitation conditions and practices during processing, to comply with 21 CFR 123.11(b). However, your firm did not monitor the prevention of cross-contamination of the RTE sandwich production line with sufficient frequency to ensure control as evidenced by observing three different employees tearing tape with their mouth, and then using the tape to hold paper that covers the stainless steel table used for assembling the RTE products.
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.
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). 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: Matthew J. Sienko, Compliance Officer, at the address given on the letterhead. If you have any questions regarding any issues in this letter, please contact Mr. Sienko at 312-596-4213.
Scott J. MacIntire