SmF Holdings, LLC – FDA 483, Mar 2, 2023

An FDA inspection conducted at Snf Holdings, LLC from February 13 to March 2, 2023, identified significant objectionable conditions related to the production of non-sterile drug products. The company received an FDA Form 483, citing three main observations, indicating potential non-compliance with the Federal Food, Drug, and Cosmetic Act and Good Manufacturing Practices. The first observation highlighted inadequate measures to prevent cross-contamination during hazardous drug production. This included using shared equipment for hazardous and non-hazardous products without deactivating agents, operators touching ancillary equipment with powder without sanitizing gloves, and shared hazardous waste bags not being changed between different product formulations within biological safety cabinets. Secondly, the firm was found to be using non-pharmaceutical grade components in their drug product formulations, which were deemed unsuitable for non-sterile drug production. Lastly, non-microbial contamination, specifically a blue residue, was consistently observed within the biological safety cabinets used for capsule production. Snf Holdings, LLC is expected to evaluate these observations and implement appropriate corrective actions to ensure product quality and safety.