Inventia Healthcare Limited – FDA 483, Jul 5, 2019

Inventia Healthcare Limited, a drug manufacturer in Thane, India, received an FDA Form 483 citing significant deficiencies in its quality control and manufacturing operations. The inspection revealed inadequate laboratory investigations for out-of-specification results, incomplete instrument calibration records, and insufficient data integrity controls for computer systems. Additionally, the firm failed to validate manufacturing processes and ensure proper training and qualification for personnel performing critical visual inspections.