FDA 483 - Intas Pharmaceuticals Ltd. - January 24, 2024
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.
An FDA inspection of Intas Pharmaceuticals Limited in Dehradun, India, revealed significant deficiencies in quality control, aseptic processing, and laboratory practices. The firm failed to conduct adequate investigations into out-of-specification results and market complaints, maintain proper environmental monitoring, and ensure the integrity of its sterile manufacturing processes. These findings indicate a lack of robust quality systems and adherence to established procedures.
ID · d70a81b4-0d15-46af-af29-56ed1c0dc3c1