Failure to maintain complaints from 2014 to 2017 landed Phoenix, Arizona-based Gergens Orthodontics Lab a Form 483 following a May FDA inspection.
Of the roughly 30 complaints the lab received from 2017 and onward, all were found deficient in recording required information such as the device name, the phone number and address of the complainant, result of the investigation and replies.
The firm also lacked documented evidence that management reviews had been performed, the agency said.
In addition, the orthodontic devicemaker did not document procedures for ensuring that suppliers complied with specified requirements.
Read the Gergens Orthodontics Form 483 here: www.fdanews.com/08-23-18-gergensorthodonticlab483.pdf.