FDA 483 - Inventia Healthcare Limited - July 05, 2019

Inventia Healthcare Limited, a drug manufacturer in Thane, Maharashtra, India, was cited with six observations during an FDA inspection. The observations highlight significant deficiencies in laboratory investigations for out-of-specification results, incomplete instrument calibration records, inadequate computer system access controls, and insufficient process validation procedures. Additionally, the firm failed to maintain complete laboratory data and lacked proper qualification for personnel performing critical visual inspections of drug products.