The FDA faulted ADB Interests for its MDR, complaint-handling and CAPA procedures.
The agency issued a Form 483 following a July/August inspection of the devicemaker’s Pearland, Texas, facility. Investigators found the firm had no MDR procedures to ensure timely evaluation of events subject to MDR reporting requirements.
The firm also lacked an adequate complaint procedure for its FasciaBlaster device, leaving customers to select “Other” on its “Contact Us” web page. Records documenting the procedure did not include the device name, unique device identifiers, the dates or results of investigations, or any corrective actions taken.
The agency identified more than 70 MDR-reportable complaints and four consumer complaints filed between June 2016 and June 2017, but the company could not produce files to show the results of investigations.