483
Avotec, Inc.FDA 483 - Avotec, Inc. - January 27, 2023
Record Details
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.
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ID · a162456e-d825-4085-a6fc-94771d653e31