FDA 483 - Imedrix Inc - July 24, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 51e450ac-1c07-4e8b-850c-8c69fa6fe2fe