Devicemaker Warned for Quality Violations of Contract Manufacturer

Despite receiving numerous complaints and initiating two product recalls, Innovative Neurotronics did not ensure its contract manufacturer met its quality requirements, according to an FDA warning letter. The company also was cited for not documenting device design changes or corrective action it took in response to complaints about defective devices. The FDA says the firm should monitor, trend and document future product complaints.
Devices & Diagnostics Letter