The FDA cited ADProducts for problems with its complaints, MDRs and contractor agreements.
Following a June inspection of the devicemaker’s Spokane, Wash., facility, the agency issued a Form 483. According to investigators, the company did not define or implement complaint handling procedures.
ADProducts documented one complaint for its AD Mirror System. The 2016 complaint did not document an evaluation for medical device reporting, and a second complaint described to investigators was not documented.
The company also had not documented procedures covering MDR or finished device acceptance. The firm had no agreement with its contractors to notify ADProducts of changes in the product or service, and had no procedures governing the requirements for contract manufacturers. The facility also lacked procedures for CAPA, quality audits or document control.