FDA 483 - Exquisite Corporation - April 26, 2023

Exquisite Corporation, a contract drug manufacturer in Baldwin Park, CA, was cited for significant deficiencies in its quality control unit, stability program, production and process controls, and equipment maintenance. The inspection revealed a lack of defined responsibilities for the quality unit, inadequate testing and validation practices, and insanitary conditions. These issues indicate a serious breakdown in the firm's pharmaceutical quality system.