FDA 483 - Next Health, LLC - November 07, 2019

An FDA inspection of Next Health, LLC in Norwalk, CT, an assembler of powered patient transfer systems, identified two significant observations. The firm was cited for inadequate procedures for design changes, specifically regarding documentation of patient weight tests and engineering change notices. Additionally, the firm failed to include a Unique Device Identifier (UDI) for its AgileLife Patient Transfer System in the device history record, as required for a Class 2 device.