FDA 483 - Veran Medical Technologies Inc - February 23, 2023

Veran Medical Technologies Inc. in Saint Louis, MO, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately report medical device adverse events, establish proper corrective and preventive actions, and thoroughly investigate device complaints. Additionally, a critical sterilization process was not revalidated after a manufacturing relocation, impacting thousands of distributed devices.