The FDA cited Reliance Mobility in a Form 483 with 13-observations after an April inspection of the company’s Columbia, Tennessee, facility.
The agency investigator found the facility had no design history files for two speech generating devices and it lacked procedures for design control. The company also lacked adequate device history records and procedures for quality audits, acceptance activities and document control.
In addition, the facility had inadequate procedures for control of labeling. For example, the procedure did not “ensure labeling is not released until a designated individual has examined the labeling for accuracy and the release, including the date and signature of the individual perfo1ming the inspection, is documented,” the agency said.
The company’s device history records for the two devices did not include the labeling for each production unit, manufacture dates, final acceptance records, or documentation of the software version downloaded into each device.
The agency also faulted the company on its complaint-handling procedure, finding that it did not properly ensure all complaints were evaluated to determine if medical device reporting was necessary or ensure that complaints received by customer support were actually logged as complaints.
The company’s procedures for reporting adverse events did not ensure completed MDRs were submitted in a timely manner or address how all information reasonably known would be submitted and it had no established CAPA procedures, the agency said.
The company also lacked procedures for control of nonconforming product or for evaluation of suppliers, contractors and consultants.