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

Source: https://www.globalkeysolutions.net/records/483/ease-seating-systems-inc/620ccd5c-ec93-4223-a3c6-5a48371ef589

> FDA 483 for Ease Seating Systems, Inc. on April 30, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ease Seating Systems, Inc.
- Inspection Date: 2024-04-30
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: 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.

## Related Officers

- [Felicia E Hinojosa](https://www.globalkeysolutions.net/people/felicia-e-hinojosa/205e8143-c9aa-45a7-8c93-d8842dc51acb)

Company: https://www.globalkeysolutions.net/companies/ease-seating-systems-inc/8fa92fa7-06a9-4760-b3a9-35286321df9a

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0