Biogen MA Inc. – FDA EIR, Jun 13, 2018

An FDA surveillance inspection of Biogen, Inc. at its Research Triangle Park, NC facility was conducted from June 4 to June 13, 2018. The inspection, performed under Compliance Program 7356.002M for Licensed Biological Therapeutic Drug Products, concluded with no significant objectionable conditions or practices observed, and no FDA Form 483 was issued. This positive outcome indicates the facility's operations were found to be compliant with good manufacturing practices. A primary focus of this inspection was to verify the implementation and effectiveness of corrective actions addressing deficiencies cited during a previous inspection in March 2017. These past issues included concerns regarding the timely updating of validated computer systems, thoroughness of product contamination investigations, material traceability in the inventory control system, prompt closure of change controls, quality oversight in Annual Product Reviews, and accuracy in shipping qualification protocols. The current inspection successfully confirmed that Biogen, Inc. had properly addressed and implemented corrections for all previously noted observations. During the 2018 inspection, verbal discussions with management led to voluntary commitments to further refine specific processes. These included clarifying work instructions and standard operating procedures for certain testing, enhancing sample description fields within software systems for better tracking, and improving the comprehensiveness of quality assurance summaries for investigations. The company promptly initiated a deviation and draft procedure to correct an identified testing process, demonstrating a proactive approach to continuous improvement. Overall, the inspection confirmed Biogen's commitment to maintaining high-quality manufacturing standards for its biological therapeutic drug substances.