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

During an inspection conducted from March 6 to March 14, 2023, the U.S. Food and Drug Administration (FDA) issued a Form 483 to a sterile drug manufacturer in Thanthewal, Himachal Pradesh, India, citing significant deficiencies in its manufacturing and quality control systems. The inspection revealed that the company's procedures to prevent microbiological contamination of sterile drug products were inadequate. Specifically, operators were observed moving articles between aseptic processing areas (Grade A and Grade B) without fully sanitizing them and without documented, approved procedures for such critical transfers, raising concerns about sterility assurance. Furthermore, the firm's quality control unit demonstrated a lack of oversight regarding crucial documentation and change management. An observation highlighted inadequate change control for a filter replacement, as it failed to identify and update all affected batch manufacturing records. Additionally, critical process documentation (SOP/PR/050) contained inaccuracies regarding the locations of non-viable particle counters, conflicting with the SCADA system and qualification protocols. These issues collectively indicate a deviation from Current Good Manufacturing Practices (CGMP) for sterile drug manufacturing. The manufacturer is required to provide a comprehensive response detailing corrective and preventive actions to address these observations and ensure future compliance.