FDA 483 - US Specialty Formulations LLC - July 02, 2024

This FDA Form 483 details seven observations from an inspection. The facility failed to ensure its quality control unit had the authority to approve/reject materials and products. Specifically, the potency of finished Sanacenia Purpurea 0.17g/ml drug product and bulk distillate was not determined prior to release, despite approximately [(b) (4)] vials of the injection drug product being released since June 2022.

Laboratory controls lacked determination of conformance to specifications for components. The written stability program for drug products did not include reliable, meaningful, and specific test methods. The established testing specification for Sanacenia Purpurea 0.17g/ml injection drug product failed to provide adequate stability data to support the labeled 12-month expiry date, and test methods were not stability-indicating. Additionally, adequate data was not provided to support the 12-month retest date for the Bulk Sanacenia.

Testing and release of drug product for distribution did not include appropriate laboratory determination of satisfactory conformance to final specifications, identity, and strength of each active ingredient prior to release. Approximately [redacted] batches of bulk distillate and [redacted] vials of finished injection drug product were released without a test method to determine potency or concentration of active ingredients.

Procedures designed to prevent microbiological contamination of sterile drug products were not followed. Reserve samples were not visually examined annually for deterioration. The firm failed to thoroughly review unexplained discrepancies and batch