Enteromedics drew a Form 483 from the FDA for producing printed circuit boards using a non-validated process, not identifying defective circuits and incorporating the nonconforming boards into its devices.
After inspecting Enteromedics’ Saint Paul, Minnesota facility from November to December 2017, the agency found that its correct and preventive actions did not properly address the issue of its Rechargeable Neuro-Regulator (RNR) devices containing circuit boards manufactured by the firm with a non-validated process.
The firm issued a recall for non-implanted devices but no actions were taken for devices already implanted in patients, the agency found.
In addition, a medical device report was not submitted for a complaint regarding a malfunctioning RNR device that caused a delay after implantation. The company also failed to submit an MDR for a patient who developed an infection at the incision site for the device.