Inspections, Compliance, Enforcement, and Criminal Investigations
Lipari Food Products, Inc 10-Oct-07
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
October 10, 2007
Mr. Thomas Lipari, President/CEO
Lipari Food Products, Inc.
26661 Bunert Road
Warren, Michigan 48089-3650
Dear Mr. Lipari:
We inspected your seafood processing facility, located at 26661 Bunert Road, Warren, Michigan, on August 14 through 27, 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 and 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 refrigerated histamine forming fish including tuna, Mahi Mahi, 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 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).
a. However your firm does not have a HACCP plan for Pacific Seafood Salad, Mermaid Salad Rotini with Crab, Lobster Pasta Salad, Seafood Salad Deluxe, Salad, Salmon Spread, Crab Spread, Krab Dip and tuna salad to control the food safety hazard of pathogen growth and toxin formation.
b. However your firm does not have a HACCP plan for Tuna Salad to control the food safety hazard of histamine.
2. 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 "PILGRIMS PRIDE TUNA SALAD" does not list the food safety hazard of histamine.
3. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 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 point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard. However, your firm's HACCP plan for "PILGRIMS PRIDE TUNA SALAD" lists a critical temperature limit, [redacted] below", at the "Receiving" and "Storage" critical control points that are not adequate to control pathogen growth. Were commend a receiving and storage critical temperature limit of 40°F or below to control the food safety hazard of pathogen growth.
4. Because 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 "PILGRIMS PRIDE TUNA SALAD" at the "Storage" critical control point to control pathogen growth is not appropriate. The corrective action listed in the plan does not assure that potentially unsafe product is not entered into commerce or corrects the cause of deficiency. Were commend that you either adjust the temperature of the cooler and/or repair the unit. We also recommend that you evaluate time/temperature exposures and not just take the temperature of an unspecified number of samples.
5. 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 procedure and frequency of "Truck Refrigeration Unit and Thermometer and Shippers Data Recorder" at the "Receiving" critical control point to control pathogen growth listed in your HACCP plan for "PILGRIMS PRIDE TUNA SALAD."
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) 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 warehousing facility 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: Judith A. Jankowski, Detroit District Office, 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have any questions regarding any issues in this letter, please contact Judith A. Jankowski at 313-393-8125.
Joann M. Givens
Detroit District Office