A warning letter posted in the most recent update by the U.S. Food and Drug Administration went out from the agency’s Denver District Office to Pinnacle Entertainment of Las Vegas. Pinnacle CEO Anthony M. Sanfilippo was told in the July 28 warning letter that a June 6 inspection of the company’s Ameristar Casino Black Hawk in Black Hawk, CO, revealed “serious deviations” from the federal seafood HACCP (Hazard Analysis and Critical Control Points) regulations. The inspection, done under contract with FDA by the Colorado Department of Public Health and Environment, found that the facility does not have a HACCP plan for vacuum-packed, cold-smoked salmon to control the food safety hazards of Clostridium botulinum toxin formation and growth of pathogens, FDA stated. Therefore, the warning letter concluded, the firm’s vacuum-packed, cold-smoked salmon is considered adulterated under federal law. FDA stated that, in order to comply with applicable regulations, the company “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 … .” The company was given 15 working days from receipt of the warning letter to respond in writing with the specific steps it intends to take to correct the deviations. “You should include in your response documentation such as your HACCP plans, copies of all related monitoring records and corrective actions, or other useful information that would assist us in evaluating your compliance. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations,” the warning letter stated. Should a company not promptly correct violations noted in a FDA warning letter, the agency may initiate regulatory action without further informal notice, including the initiation of a seizure action against food products and/or action to stop the firm from operating. Recipients of FDA warning letters have 15 working days from receipt to respond with details of the procedures they have taken, or will take, to correct the current violations and prevent them from recurring.
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