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 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 investigation.
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.
Investigators found the firm had not defined or implemented a CAPA procedure for processes, or returned products. Managers said 70 MDRs had been filed over the previous 12 months involving injuries related to the FasciaBlaster device, but no CAPAs had been initiated to address them.