| Public Health Service Food and Drug Administration |
| Cincinnati District Office Central Region 6751 Steger Drive Cincinnati, OH 45237-3097 Telephone: (513) 679-2700 FAX: (513) 679-2771 |
Department of Health and Human ServicesREVISED WARNING LETTER
CIN-10-82644-07
Via Federal Express
March 10, 2010
Craig F. Maier, President and CEO
Frisch's Restaurant, Inc.
2800 Gilbert Avenue
Cincinnati, OH 45206
Dear Mr. Maier:
We inspected your seafood processing facility, located at 3011 Stanton Avenue, Cincinnati, OH 45206 on September 03-04 and 17-18, 2009, and conducted a limited follow up inspection on January 6-8, 2010. 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. 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 salad is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it 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 123.6(c)(1). However, your HAACP plan for "Tuna Salad" does not list the chemical food safety hazard of"Histamine," which is reasonably likely to occur in the event of temperature abuse, or physical food safety hazards for metal due to the use of metal mixing machines during processing.
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: Mark E. Parmon, Compliance Officer, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have questions regarding any issues in this letter, please contact Mr. Parmon at 513-679-2700, Ext. 162, or at mark.patmon@fda.hhs.gov.
Sincerely,
/s/
Karen Gale Seg
Acting District Director
Cincinnati District
Cc: Ms. Linda Matiin
Supervisor
Frisch's Commissary
3011 Stanton Avenue
Cincinnati, OH 45206-1150
Mr. Charles Kirchner
Chief, Food Safety Division
Ohio Department of Agriculture
8995 East Main Street
Reynoldsburg, OH 43068-3399
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