FDA WARNING_LETTER - TEI Biosciences, Inc. - November 02, 2018

The FDA conducted an inspection of TEI Biosciences, Inc., an Integra LifeSciences Company, from October 9 to November 2, 2018, at their Boston, MA facility. The inspection revealed that the firm's collagen-based medical devices, including Xenform Soft Tissue Repair Matrix, are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation 21 CFR Part 820.

Key violations include: 1. **Failure to validate processes (21 CFR 820.75(a)):** The firm failed to adequately validate the (b)(4) process for extracellular bovine matrix (EBM) devices and lacked data to demonstrate adequate validation of bacterial endotoxin testing. Discrepancies were noted in sampling size for endotoxin verification and modifications to testing procedures without demonstrating impact on results. 2. **Failure to prevent contamination (21 CFR 820.70(e)):** The firm lacked data to demonstrate bacterial endotoxin testing of the (b)(4) Water System used for EBM device manufacturing and was not routinely performing microbial identifications. 3. **Failure to control environmental conditions (21 CFR 820.70(c)):** A sporicidal disinfectant had not been used in ISO 7 clean rooms since March 2017, despite