FDA 483 - Biogen MA Inc. - June 16, 2021

During an FDA inspection from June 7-16, 2021, Biogen Inc., a drug substance manufacturer located in Research Triangle Park, NC, was issued a Form FDA 483 detailing significant observations. The inspection revealed inadequate documentation and traceability for quality control laboratory analyst training samples. Pervasive deficiencies in facility and equipment maintenance were noted within the Large Scale Manufacturing building, including various leaks, deteriorated materials, and unaddressed residue, indicating a lack of proper upkeep. The FDA also observed contamination events in stored biological materials due to insufficient sanitization, with no effectiveness checks for implemented corrective actions. Furthermore, method validation for bioburden detection in long-term stored materials was incomplete, and a critical GMP utility was inadequately installed, posing a risk of back siphonage. The company also failed to adhere to or maintain adequate standard operating procedures concerning equipment cleanliness verification, proper securing of intermediate bulk containers, consistent logbook reviews, and appropriate labeling and tracking of samples. These observations highlight a need for Biogen to address compliance with current Good Manufacturing Practices, requiring prompt corrective actions and a detailed response to the FDA to ensure product quality and integrity.