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

TEI Biosciences, Inc. received a Form 483 citing significant deficiencies in quality system controls for their implantable medical devices. Observations included failures in controlling nonconforming product, establishing corrective and preventive actions, validating critical test methods (like bacterial endotoxin and bioburden), preventing contamination, validating production software, and managing storage areas. These issues collectively indicate a lack of robust quality oversight impacting product sterility and safety.