FDA 483 - Veran Medical Technologies Inc - July 29, 2021

An FDA inspection of Veran Medical Technologies Inc. in Saint Louis, MO, revealed significant deficiencies in their quality system, particularly concerning sterilization processes, product non-conformance, and risk management for their Always-On Tip Tracked pulmonary biopsy medical devices. Repeated observations from a prior inspection indicate persistent issues with process validation, specifically regarding relative humidity specifications for sterilization, and inadequate control over non-conforming products and rework activities. Furthermore, the firm's sampling methods for sterile product integrity and its risk analysis for device hazards, including high failure rates, were found to be incomplete or inadequate.