Tennessee Devicemaker Cited for Risk Analysis, Labeling
The FDA hit Nashville-based CNMC Company with a Form 483 over inadequate risk analysis and device labeling procedures observed by an agency investigator during a March inspection.
The firm’s procedures for controlling and inspecting device labeling did not document label release. The facility did not document any label inspections or releases for its EquiDose II Diode Detector dose monitors.
The company performed an incomplete risk analysis for its Model 206 Electrometer device, failing to address possible hazards related to functional failures, energy and maintenance. The analysis did not fully address potential environmental hazards, such as using the device outside its intended environment, or possible usage related hazards, such as usage by untrained personnel or inadequate labeling.