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

During an inspection conducted from September 29 to October 3, 2025, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to Aucta Pharmaceuticals, Inc. of Piscataway, NJ. The primary observation noted was the company's failure to adhere to its established written production and process control procedures. Specifically, Aucta Pharmaceuticals did not perform a required performance qualification (PQ) study for a mixer (equipment# (b)(4)) used in the manufacturing of its (b)(4) Oral Suspension (b)(4) (b)(4) (d)(4)) drug product. This omission occurred despite the equipment being utilized in process validation batches, and the company's own "Validation Master Plan" (Document# QMS0040, Section 3.2.6) mandating that Installation Qualification (IQ), Operational Qualification (OQ), and PQ be completed for all equipment involved in manufacturing process validation studies. This finding indicates a deviation from the company's quality system requirements. Under the regulatory framework of the Federal Food, Drug and Cosmetic Act, particularly Section 704(b), such observations require the company to evaluate and implement appropriate corrective actions to ensure compliance with good manufacturing practices and its internal quality standards. The FDA expects a timely response detailing how the identified issues will be remediated.