FDA WARNING_LETTER - Raw Bistro, Inc. - September 29, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Raw Bistro Inc. following an inspection of its pet food manufacturing facility from September 16-29, 2025. The inspection, a follow-up to a prior regulatory meeting, revealed significant violations of FDA"s Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals regulations (21 CFR Part 507).

The primary issues stemmed from inadequate preventive controls, resulting in adulterated products. FDA sampling of Raw Bistro Dog Fare Grass-Fed Beef Entrée confirmed the presence of Salmonella Paratyphi, leading to a Class I recall. The company"s wash, intended as a preventive control for pathogens like Salmonella and Listeria monocytogenes, was deemed ineffective, further evidenced by Listeria species found on food contact surfaces. Additionally, Raw Bistro Inc. failed to adequately validate its preventive control process and did not conduct a comprehensive hazard analysis to include potential nutrient deficiencies or toxicities in its dog food products.

The FDA requires Raw Bistro Inc. to provide a written response within fifteen working days detailing specific corrective actions taken, including supporting documentation, to address these violations and prevent recurrence. The FDA also noted the inadequacy of some proposed corrections, such as temperature monitoring and finished product testing, as they do not sufficiently minimize or prevent hazards. Failure to adequately address these concerns may result in further legal action.