483
Aspiro Pharma LimitedFDA 483 - Aspiro Pharma Limited - October 07, 2021
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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.
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ID · 7916592a-8c6d-4ccc-92c1-7b022fa8a02d