FDA 483 - A.P. Deauville, LLC - January 23, 2025

A.P. Deauville, LLC, an antiperspirant drug manufacturer in Easton, PA, was cited for numerous and severe Good Manufacturing Practice (GMP) violations during an FDA inspection from January 13-23, 2025. The observations highlight systemic failures in quality control, investigations, laboratory records, production and process controls, method validation, material testing, stability programs, equipment maintenance, personnel training, yield determination, complaint handling, and annual product reviews, many of which are repeat observations from previous inspections and a 2019 Warning Letter. The firm also distributed drug products without expiration dates supported by stability data.