FDA 483 - Immacule Lifesciences Private Limited - September 18, 2025

An FDA inspection of Immacule Lifesciences Private Limited in Solan, India, revealed critical deficiencies across its sterile drug product manufacturing operations. The firm's quality unit failed to ensure cGMP compliance and adequate environmental monitoring, while aseptic processing procedures were not properly established or followed, leading to contamination risks. Significant issues were also noted in equipment design, environmental monitoring systems, aseptic process validation, computerized system controls, laboratory investigations, and employee training, indicating a systemic lack of adherence to quality and sterility assurance for products destined for the USA market.