FDA 483 - Cirtronics Corporation - October 12, 2023

Cirtronics Corporation in Milford, NH, was inspected by the FDA from October 10-12, 2023. The inspection revealed that the firm's procedures for corrective and preventive action (CAPA) were not adequately established. Specifically, effectiveness checks for CAPAs were not consistently completed before the actions were closed, indicating a deficiency in their quality system.