# FDA 483 - Accessibility Services, Inc. - March 25, 2022

Source: https://www.keypedia.com/records/483/accessibility-services-inc/44ff68f0-b1a1-46d0-a1e3-3cdcd332dfd1

> FDA 483 for Accessibility Services, Inc. on March 25, 2022. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Accessibility Services, Inc.
- Inspection Date: 2022-03-25
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Accessibility Services, Inc., a medical device manufacturer in Homosassa, FL, was cited with seven observations during an FDA inspection. The inspection revealed significant deficiencies in their quality system, including a lack of established procedures for purchasing control, acceptance activities, installation, training, design control, Medical Device Reporting, and quality audits. Many of these issues were repeat observations from a previous inspection, indicating persistent non-compliance with quality system requirements.

## Related Officers

- [Miaja Umaedi](https://www.keypedia.com/people/miaja-umaedi/0a41661f-08bb-4523-ab09-b17e230068e0)

Company: https://www.keypedia.com/companies/accessibility-services-inc/086ddd97-71fa-472f-a38e-49ca0505dd23

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7