FDA 483 - Inventia Healthcare Limited - February 12, 2025

Inventia Healthcare Limited, a drug manufacturer in Thane, Maharashtra, India, was cited for significant quality control and manufacturing deficiencies during an FDA inspection. Observations included a failure to thoroughly investigate numerous unexplained discrepancies, out-of-specification results, and customer complaints, as well as issues with equipment design and maintenance. The firm also demonstrated a lack of adequate quality control unit authority in reviewing production records and insufficient controls over computer systems.