FDA 483 - INVENT MEDICAL CORPORATION - April 23, 2025

INVENT MEDICAL CORPORATION, a manufacturer in Carlsbad, CA, was inspected by the FDA. The inspection revealed issues with the documentation of corrective and preventive action (CAPA) activities. Specifically, several CAPA records were missing information, including signatures and updates, and some were not closed within a reasonable timeframe per the firm's procedure.