483
Aucta Pharmaceuticals, Inc.Aucta Pharmaceuticals, Inc. – FDA 483, Oct 3, 2025
Record Details
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.
View Company Profile
ID · 04b2586e-46db-4320-ad8e-9157e80e719a
Other documents for Aucta Pharmaceuticals, Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.