Inspections, Compliance, Enforcement, and Criminal Investigations
Walter's Seafood, Inc. 08-Aug-08
Department of Health and Human Services
Public Health Service
555 Winderley Pl., Ste. 200
RETURN RECEIPT REQUESTED
August 8, 2008
Walter R. Lippke
Owner and President
Walter's Seafood, Inc.
10251 Metro Pkwy., Ste. 120
Fort Myers, FL 33912-1010
Dear Mr. Lippke:
We inspected your seafood processing facility, located at 10251 Metro Pkwy Ste 120, Fort Myers, FL 33912-1010 on April 15-17, 2008. 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 Scombroid-toxin forming fish species (Mahi Mahi, Tuna, Wahoo, Mackerel, etc.), Canned Pasteurized Crab Meat, and Ready to Eat Stone Crab Claws 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 implement the record keeping systems that you listed in your HACCP plans, to comply with 21 CFR 123.6(b).
However, your firm did not record monitoring observations at the "Receiving" critical control points to control the hazard of pathogen growth listed in your HACCP plan for "Cooked Crab Products (Pasteurized Crab Meat)."
2. You must have a HACCP plan that, at a minimum, lists monitoring procedures for each critical control point to ensure compliance with the critical limits, to comply with 21 CFR 123.6 (c)(4). However, your firm's HACCP plan for Scombroid-toxin forming species (Mahi Mahi, Tuna, Wahoo, Mackerel, etc.) lists a monitoring procedure of "2 times daily to check if recorder to check if recorder is working." This monitoring procedure is not adequate to ensure compliance with the critical limit of maintaining "40 degrees f. in cooler" and keeping "histamine type fish iced while in cooler."
3. 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 procedure of monitoring "Cooler temp" at the "Storage" critical control point to control histamine listed in your HACCP plan for Scombroid-toxin forming species. Specifically, your HACCP plan specifies that you will monitor the cooler temperature by using a recorder thermometer. However, monitoring with a recorder thermometer, requires a continuous monitoring device and our inspection revealed that you do not have such monitoring equipment.
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 Scombroid forming species (Mahi Mahi, Tuna, Wahoo, Mackerel, etc.), at the critical control point of "Receiving" is inadequate in that it does not include appropriate actions for temperature deviations such as, investigating the cause of the critical limit deviation, and measures taken to prevent the recurrence of the deviation such performing histamine testing or holding the product for evaluation and discontinue the use of the supplier.
However, your corrective action plan for "Cooked Crab Products (Pasteurized Crab Meat)", at the critical control point of "Receiving" is inadequate in that it does not include appropriate actions for temperature deviations such as, investigating the cause of the critical limit deviation, and measures taken to prevent the recurrence of the deviation such performing histamine testing or holding the product for evaluation and discontinue the use of the supplier.
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 U.S. Food and Drug Administration, Attention: Winston R. Alejo, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have questions regarding any issues in this letter, please contact Mr. Alejo at (407) 475-4731.
Emma R. Singleton
Director, Florida District