FDA 483 - TEI Biosciences, Inc. - November 12, 2021

TEI Biosciences, Inc. in Boston, MA, was inspected and cited for significant deficiencies in quality system procedures. Observations included inadequate process parameter monitoring, unvalidated manufacturing processes, insufficient environmental control, and incorrect product labeling with extended expiration dates. Additionally, the firm failed to submit multiple Medical Device Reports for serious injuries and malfunctions within the required 30-day period.