FDA 483 - Imedrix Inc - July 24, 2024

Imedrix Inc. in Milpitas, CA, a manufacturer of KardioScreen, was cited for numerous deficiencies in its quality system during an FDA inspection. The firm failed to adequately document corrective and preventive actions, conduct proper management reviews, maintain complaint files, and ensure personnel training. Significant issues also included inadequate supplier evaluation, lack of records for non-reportable corrections, incomplete risk analysis, and poor document control.