483
ENDO USA, Inc.FDA 483 - ENDO USA, Inc. - April 14, 2023
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An FDA inspection of Par Sterile Products LLC in Rochester, MI, revealed significant deficiencies in aseptic processing for sterile drug products. The firm failed to follow procedures for documentation of interventions, cleaning and disinfection, and aseptic setup and filling operations. These issues collectively indicate a high risk of microbiological contamination of sterile products.
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