FDA EIR - Brava, LLC - September 19, 2018

An FDA inspection of BRAVO! LLC, a manufacturer of freeze-dried, smoked, and frozen raw pet food and treats, was conducted on September 19, 2018. The purpose was to assess the company's compliance with the new Animal Food Regulations (21 CFR Part 507), focusing on Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventative Controls. This marked their initial inspection under these updated rules.Key issues identified included a critical flaw in the patty manufacturing process: product that had undergone a pathogen reduction treatment (High-Pressure Processing) was subsequently re-opened and handled near untreated raw materials, creating a significant risk of recontamination. Management acknowledged this and plans to revise the process, exploring options like pre-packaging patties or sequencing production to prevent cross-contamination. Another major finding was the absence of written records for employee training in animal food hygiene and safety, a requirement under the new regulations. The company committed to establishing a formal training program and documentation system.Furthermore, a previously noted issue from a 2014 inspection—a pitted concrete floor in the smoke room—remained unaddressed. The 2014 inspection had led to observations of manufacturing deficiencies and a formal communication from the FDA regarding insufficient processes to mitigate pathogenic contamination, particularly Listeria monocytogenes. While BRAVO! LLC has since implemented High-Pressure Processing for raw meat and sanitation checks, the FDA emphasized the need for comprehensive process controls and a robust Food Safety Plan. The company has committed to developing these to ensure ongoing compliance and product safety.