FDA 483 - Vesco Medical Llc - October 31, 2023

Vesco Medical Llc, a specification developer in Westerville, OH, was cited for significant deficiencies in its quality management system during an FDA inspection. Observations included a failure to adequately establish corrective and preventive actions, a lack of design control procedures for medical devices, and insufficient investigation of customer complaints regarding device failures. Additionally, the firm failed to properly evaluate its Class I suppliers according to its own purchasing controls.