FDA 483 - Immacule Lifesciences Private Limited - March 14, 2023

An FDA inspection of Immacule Lifesciences Private Limited, a sterile drug manufacturer in Thanthuwal, India, revealed significant deficiencies in aseptic processing and quality control. Observations included a lack of established and followed procedures to prevent microbiological contamination during sterile drug production, and an inadequate quality control unit failing to properly approve and reject procedures and specifications, as evidenced by issues with change control and inaccurate particle counter listings.