BRAVO! LLC – FDA EIR, May 28, 2014

The FDA conducted an inspection of BRAVO! LLC, a frozen raw pet food manufacturer in Manchester, CT, from May 7-28, 2014. This inspection was prompted by reports from the State of New Mexico revealing Listeria monocytogenes contamination in the company’s Beef Blend and Turkey Balance pet food products. The regulatory framework for this inspection was the Feed Contaminants Program (Microbial Agents). A seven-item FDA Form 483 was issued, detailing significant violations. These included the failure to take reasonable precautions to prevent product contamination, as demonstrated by the Listeria findings. Other critical issues identified were the improper maintenance of hand washing facilities, with employees observed cleaning equipment in hand sinks; inadequate backflow prevention on potable water hoses, creating cross-contamination risks; and poorly maintained food contact surfaces, showing exposed porous metal and rough welds that impede effective sanitation. The inspection also noted inaccurate thermometers and inadequate floor maintenance, which could contribute to contamination. Additionally, the firm used USDA beef designated 'Not for Human Consumption' in pet food production without obtaining prior FDA diversion approval. BRAVO! LLC also lacked formal written procedures for handling customer complaints and product recalls. In response, BRAVO! LLC initiated a voluntary recall of the affected pet food products. The company's management committed to implementing corrective actions, including retraining employees, installing a dedicated equipment cleaning station, rectifying water system deficiencies, repairing food contact surfaces, and ensuring accurate temperature monitoring. A written response to the FDA 483 was required within 15 business days.