FDA 483 - Whele LLC DBA Perch - June 06, 2022

Whele LLC DBA Perch, an initial importer of medical devices, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately establish and implement procedures for complaint handling, Medical Device Reporting (MDR), supplier quality, sampling plans, personnel training, corrective and preventive actions (CAPA), and document control. These issues led to uninvestigated complaints, unreported adverse events, and a lack of control over critical quality processes for products like the Mighty Bliss Electric Heating Pad and CareTouch monitoring systems.