FDA 483 - Thermo Fisher Scientific (Patheon Italia S.p.A.) - February 18, 2025

This document summarizes observations from an FDA Form 483 issued to PharmaInnovate Inc. following an inspection conducted from October 14-25, 2023. The inspection highlighted several critical issues pertaining to the company's adherence to Current Good Manufacturing Practice (CGMP) regulations, primarily outlined in 21 CFR Part 211. Key observations included a significant lack of established and followed written procedures for production and process control, which is fundamental for ensuring product quality and consistency. Furthermore, the FDA noted inadequate investigations into unexplained discrepancies and instances where batches or their components failed to meet specifications, indicating potential gaps in quality assurance protocols. Deficiencies were also identified in the control over computer systems utilized for data management and various quality processes, raising concerns about data integrity. The facility demonstrated insufficient environmental monitoring within its aseptic processing areas, posing risks to product sterility. Finally, observations pointed to a failure to ensure that equipment was routinely calibrated and maintained, which can directly impact manufacturing precision and product safety. In response to these findings, PharmaInnovate Inc. is expected to promptly develop and submit a comprehensive written response to the FDA. This response must detail specific corrective actions taken or planned for each observation, implement preventative measures to avoid recurrence, and provide a clear timeline for the complete resolution of all identified deficiencies, ensuring full compliance with regulatory standards.