FDA 483 - TEI Biosciences, Inc. - November 02, 2018

TEI Biosciences, Inc. in Boston, MA, was cited for significant deficiencies in contamination control, process validation, and quality system procedures during an FDA inspection. Observations included inadequate bacterial endotoxin testing for EBM medical devices like Xenform Soft Tissue Repair Matrix, insufficient environmental controls in ISO 7 clean rooms, and failures in corrective and preventive actions. The firm also lacked proper quality agreements and oversight for critical suppliers, indicating systemic quality control issues.