FDA 483 - Whele LLC DBA Perch - July 18, 2023

Whele LLC DBA Perch, an initial distributor/importer in Boston, MA, was cited with four repeat observations during an FDA inspection. The firm failed to adequately establish procedures for complaint handling, corrective and preventive actions, and control of non-conforming products. Additionally, the firm did not submit Medical Device Reports (MDRs) within the required 30-day timeframe for serious injuries.