FDA 483 - Aspiro Pharma Limited - October 07, 2021

Aspiro Pharma Limited, a sterile pharmaceutical manufacturer in Siddipet, Telangana, India, received a Form 483 with repeat observations. The inspection revealed significant failures in quality control, including inadequate review of discrepancies, insufficient trending of root causes for corrective actions, and a failure to properly record and justify deviations during manufacturing. These issues indicate a systemic weakness in their quality management system.