|Company:||Blue Ribbon Meats Inc|
|Subject:||Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions|
|Issuer:||Cincinnati District Office|
|Issued:||Feb. 14, 2008||Closed:||
Department of Health and Human Services
Public Health Service
Cincinnati District Office
Via Federal Express
WARNING LETTER CIN-08-34437-10
February 14, 2008
Albert J. Radis, President
Blue Ribbon Meats, Inc.
3316 West 67th Place
Cleveland, OH 44102
Dear Mr. Radis:
We inspected your seafood processing facility, located at 3316 W. 67th Pl., Cleveland, OH from September 20 to October 9, 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 various seafood 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 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 have a HACCP plan that lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4):
• Your firm's HACCP plan for pasteurized canned crabmeat does not list the monitoring procedures and their frequency at the receiving critical control point to control the hazard of Clostridium botulinum. Given that your firm receives pasteurized canned crabmeat transported over an extended period of time (in excess of 4 hours), we recommend that you either: 1) require transporters to provide records showing that products have been held at safe temperatures throughout transport, or 2) use some other equivalent method of ensuring the safe conditions were maintained throughout shipping.
• Your firm's HACCP plan for pasteurized canned crabmeat does not list the monitoring procedures and their frequency at the storage critical control point to control the hazard of Clostridium botulinum. The continuous monitoring system should be visually checked at least once per day. Also, your HACCP plan should reflect your firm's use of a continuous monitoring system and state that the monitoring frequency is continuous.
2. You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) . However, your firm did not record monitoring observations at the storage critical control point to control the hazard of C. botulinum toxin formation listed in the HACCP plan for pasteurized canned crabmeat. Specifically, your firm does not maintain legible continuous temperature monitoring records. Your firm uses recording charts that are designed to record seven days worth of data. However, your firm routinely uses the recording charts to record data in excess of seven days, in some cases up to 62 days of data were recorded on one chart. Our review found that instead of having 35 charts covering a 35 week period, your firm only used seven charts.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your firm 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 Federal Food, Drug and Cosmetic Act and all applicable regulations.
You should take prompt action to correct these violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice. These actions include, but are not limited to, seizure and/or injunction.
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.
Please send your reply to the U.S. Food and Drug Administration, attention: Karen Gale Sego, Compliance Officer, 6751 Steger Dr., Cincinnati, OH 45237. If you have questions regarding any issues in this letter, please contact her at (513) 679-2700 extension 164.
Carol A. Heppe
cc: Charles Kirchner, Chief, Food Safety Division
Ohio Department of Agriculture
8995 East Main Street
Reynoldsburg, OH 43068-3399