483
Aspiro Pharma LimitedAspiro Pharma Limited – FDA 483, Oct 7, 2021
Record Details
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.
View Company Profile
ID · 7916592a-8c6d-4ccc-92c1-7b022fa8a02d
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.