FDA 483 - ENDO USA, Inc.

An FDA inspection of Par Sterile Products, LLC in Rochester, Michigan, a drug product manufacturer, revealed significant deficiencies in manufacturing process validation and quality unit procedures. Observations included unvalidated capping/crimping machines, inadequate personnel monitoring for aseptic gloves, and a lack of written procedures for decontamination and aseptic processing behavior. These issues indicate a need for improved control and documentation of critical manufacturing operations.