FDA 483 - ENDO USA, Inc.
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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.
- Company
- ENDO USA, Inc.
- Product Type
- Drugs
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