A seafood-processing facility in Gloucester, MA, found with “significant violations” of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation was warned Sept. 26 about corrections that it must make to avoid further action by the U.S Food and Drug Administration (FDA). In the FDA warning letter, Intershell International Corp. was told that its pasteurized canned crabmeat is adulterated because of the “noted violations.” Among these were not having conducted a hazard analysis and not having a HACCP plan adequate for controlling the food-safety hazard of Clostridium botulinum toxin formation, the agency stated. Further, FDA advised the seafood processor that it must implement the monitoring procedures and frequency that are necessary to control the botulism toxin. In addition, the agency stated that the seafood processor must address inadequate record-keeping of continuous temperature-monitoring devices. FDA also found that the seafood processing facility’s corrective action plan for “refrigerated pasteurized canned crabmeat is not appropriate.” “Specifically, your corrective action plan does not include procedures to bring affected products back under temperature control or procedures to investigate the root cause of the deviation to ensure control of the process,” the warning letter from FDA’s New England District stated. The warning letter followed Aug. 22, 25 and 29 inspections of the Gloucester facility by FDA. Inspection findings, including FDA form 483, were provided to the company on Aug. 29, and it responded back on Sept. 9. FDA requested a response to the warning letter be returned within 15 working days.