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.

In addition, the device’s hazard of incorrect measurement is considered negligible “although resulting measurements may have a direct relationship to the accuracy of the radiation therapy dose delivered,” the agency said.

The firm also failed to analyze service reports to identify and predict quality issues. Between January 2017 and February 2018, it did not analyze receiving and service records that it initiated. Some service reports were missing required information, such as the date of service, the test and inspection data and the personnel servicing the device.

The investigator cited the firm’s failure to document the results of corrective and preventive actions. Out of seven closed CAPA request forms that were initiated since January 2016, five had no documentation of the results of planned corrective actions and they all lacked documentation of the results of proposed verification activities.

In another observation, the agency official noted that the firm’s rework and reevaluation activities were not fully recorded in the device history record. Specifically, the firm did not document the details of rework performed on a Model 206 feedback module assembly. The nature of the rework performed should have been documented on a product rework record and an engineer needed to approve it first.

The device history record contained no documentation of the type of rework and/or repair activities performed, or any engineering approval of repairs, the agency said.