FDA EIR - Brava, LLC - September 19, 2018

An FDA inspection of BRAVO! LLC, a manufacturer of pet food and treats, was conducted on September 19, 2018. This inspection was the initial assessment under the new Animal Food Regulations (21 CFR Part 507), focusing on Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventative Controls. The inspection identified two primary concerns. Firstly, the design of the patty manufacturing process posed a significant risk of recontamination. Specifically, previously High-Pressure Processed (HPP) treated product was opened and further processed in close proximity to untreated raw animal food, creating a pathway for contamination. Management acknowledged this hazard and is exploring solutions, including altering the packaging process or implementing production sequencing to segregate operations. Secondly, the company lacked written records documenting employee training in animal food hygiene and safety principles, a requirement under the new regulations. Management committed to establishing a formal training program and maintaining records, expecting completion within a month for records and longer for a full Food Safety Plan. Additionally, an observation from a previous May 2014 inspection—a pitted floor in the smoke room—remained uncorrected. The 2014 inspection, prompted by Listeria findings and a recall, also led to an Untitled Letter regarding insufficient contamination mitigation. While many past issues were resolved, the overarching need for robust process controls for pathogenic contamination, as highlighted in the Untitled Letter, was reiterated during the current inspection, emphasizing the need for environmental monitoring in conjunction with sanitation.