FDA 483 - A.P. Deauville, LLC - May 02, 2019

A.P. Deauville, LLC was cited for numerous deficiencies across its manufacturing, quality control, and laboratory operations. The inspection revealed significant issues including inadequate complaint handling, lack of process validation, poor equipment cleaning, and insufficient stability testing. Furthermore, the firm demonstrated a lack of employee training, incomplete laboratory records, uncalibrated instruments, and unsanitary facility conditions, indicating a systemic failure to adhere to good manufacturing practices.