FDA 483 - Avotec, Inc. - January 27, 2023

Avotec, Inc. in Stuart, FL, was inspected by the FDA from January 23-27, 2023, regarding its manufacturing operations for class 2 medical devices. The inspection revealed significant deficiencies in the firm's quality system, including inadequate complaint handling records, lack of documented employee training requirements, and a failure to conduct required quality audits. One observation was a repeat from a previous inspection, indicating persistent issues.