FDA 483 - Amsino Healthcare (USA) Inc - September 20, 2021

Amsino Healthcare (USA) Inc. in Vernon Hills, IL, was cited for multiple deficiencies during an FDA inspection from September 7-20, 2021. Key issues include inadequate process validation for smoke studies, poorly established and documented corrective and preventive actions, and a failure to appoint a permanent Quality Director. The firm also had issues with equipment cleaning, thoroughness of investigations into discrepancies and batch failures, and procedures for preventing microbiological contamination of sterile drug products.