Inspections, Compliance, Enforcement, and Criminal Investigations
Midwest Seafood, Inc. 16-Dec-05
Department of Health and Human Services
Public Health Service
Cincinnati District Office
VIA FEDERAL EXPRESS
December 16, 2005
Lauren Easton Enz,
Chief Operating Officer
Midwest Seafood, Inc.
475 Victory Drive
Springboro, OH 45066-3047
WARNING LETTER CIN 06-28136-04
Dear Ms. Easton Enz:
We inspected your seafood processing facility, located at 475 Victory Drive, Springboro, OH, on October 11 and 12, 2005. We found that you have serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulations, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulations for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Parts 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 tuna and mahi-mahi products 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 regulations 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 implement the monitoring procedures that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm did not follow the monitoring procedure of recording the processing times on your firms "pull sheets" in order to control the hazard of histamine formation in histamine forming fish such as tuna and mahi-mahi.
You must retain monitoring records at the processing facility for at least one year from the day they were prepared for fresh products such as tuna and mahi-mahi in order to comply with 21 CFR 123.9(b)(1). However, your firm did not appear to have any monitoring records for these 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 regulations (21 CFR Part 123), and the Current Good Manufacturing Practice regulations (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: Stephen J. Rabe, Compliance Officer. If you have questions regarding any issues in this letter, please contact Mr. Rabe at 513-679-2700, extension 163.
Carol A. Heppe