FDA 483 - Amsino Healthcare (USA) Inc - November 13, 2023

Amsino Healthcare (USA) Inc, a sterile drug and device manufacturer in Vernon Hills, IL, received a Form 483 with four observations. The inspection revealed repeat issues with the firm's failure to thoroughly investigate discrepancies and product impact from microbial contamination in its water system, alongside deficiencies in quality control unit procedures. Additionally, the firm failed to submit a Medical Device Reporting (MDR) report for a device malfunction and exhibited inadequate procedures for complaint evaluation, particularly concerning MDR reporting.