FDA 483 - Aucta Pharmaceuticals, Inc. - October 03, 2025

An FDA inspection of Aucta Pharmaceuticals, Inc. in Piscataway, NJ, revealed a significant deviation from written production and process control procedures. The firm failed to conduct a required performance qualification study for a mixer used in the manufacturing of a drug product, (b) (4) Oral Suspension. This indicates a lapse in equipment validation and adherence to internal quality management plans.