FDA 483 - Strides Pharma Science Limited - February 24, 2023
Discuss this record with AI
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.
Strides Pharma Science Limited in Puducherry, India, received an FDA Form 483 citing significant quality system deficiencies. The firm failed to thoroughly investigate discrepancies and recurring out-of-specification results, and its quality control unit procedures were inadequate regarding shipping studies and equipment breakdown management. Additionally, the inspection revealed visibly dirty manufacturing equipment, incomplete master production records, and poor control over computerized systems, including uninvestigated alarms and shared user credentials.
ID · 30a1bd64-df97-4f8c-b4b5-a92e689b62bb