FDA 483 - Ease Seating Systems, Inc. - April 30, 2024

Ease Seating Systems, Inc. in Clio, MI, a medical device specification developer, was cited for significant deficiencies across four observations during an FDA inspection. The firm failed to adequately establish procedures for complaint handling, design control, and supplier approval for its Class 2 Ease Cushion device. Additionally, the unique device identifier (UDI) on the product label did not match the information reported to the FDA's GUDID.