Accessibility Services, Inc. – FDA 483, Mar 25, 2022

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.