TEI Biosciences, Inc. – FDA 483, May 17, 2023

TEI Biosciences, Inc. received an FDA Form 483 following an inspection from March 1 to May 17, 2023. The manufacturer of collagen-based implantable medical devices was cited for several significant quality system deficiencies, indicating non-compliance with regulatory requirements for Good Manufacturing Practices (GMPs).The primary issues centered on inadequate control of nonconforming products, including the release of devices with out-of-specification bacterial endotoxin levels and insufficient bioburden testing, without proper investigation or risk assessment. Procedures for Corrective and Preventive Actions (CAPA) were found to be deficient, notably in addressing an internal complaint about GMP failures across multiple product lots and failing to include patient complaints in health hazard evaluations. This was a repeat observation.Furthermore, the company lacked adequate validation for critical processes, specifically for its bacterial endotoxin (BET) detection program and bioburden test methods, deviating from established compendial standards. The software used for recording critical measurements was not adequately validated, allowing for editable records rather than permanent ones. Control of storage areas was also found lacking, with sterile devices mislabeled. Finally, an out-of-tolerance bacterial endotoxin testing instrument was not adequately investigated for its impact on product quality, and affected products were not contained.TEI Biosciences, Inc. is required to provide a comprehensive response to the FDA, detailing the corrective actions taken or planned to address each observation and ensure compliance with regulatory standards for medical device manufacturing.