FDA WARNING_LETTER - Blue Ribbon Meats Inc - October 09, 2007

The FDA inspected Blue Ribbon Meats, Inc. from September 20 to October 9, 2007, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice regulation (21 CFR Part 110). These violations render the firm's seafood products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key deficiencies include the firm's HACCP plan for pasteurized canned crabmeat lacking monitoring procedures and frequencies for critical control points at receiving and storage to control Clostridium botulinum, as required by 21 CFR 123.6(c)(4). Additionally, the firm failed to implement the record-keeping system listed in its HACCP plan, specifically not maintaining legible continuous temperature monitoring records for storage, with recording charts being used for periods far exceeding their design, violating 21 CFR 123.6(b). The FDA requires prompt corrective action and establishment of procedures to prevent recurrence. The firm must respond in writing within fifteen working days, detailing specific corrections and providing supporting documentation. Failure to comply may result in regulatory actions such as seizure and/or injunction.