FDA 483 - Intas Pharmaceuticals Limited - May 12, 2023

Intas Pharmaceuticals Limited received a Form 483 citing significant deficiencies across multiple areas of its manufacturing operations. Key issues include data manipulation in visual inspection records, inadequate process controls for tablet manufacturing, and a systemic failure to thoroughly investigate discrepancies and identify root causes. The firm also demonstrated deficiencies in aseptic processing validation, environmental monitoring, data integrity controls for computerized systems, and the overall effectiveness of its Quality Control Unit.