FDA 483 - Oxygen Therapy Institute - November 17, 2023

Oxygen Therapy Institute, a medical device manufacturer in Jacksonville, FL, was cited with twelve observations during an FDA inspection from November 13-17, 2023. The findings indicate significant deficiencies across multiple quality system areas, including a lack of established procedures for acceptance activities, supplier qualification, process controls, quality audits, complaint handling, nonconforming product, CAPA, MDRs, device history records, training, management review, and document approval. Many of these issues are repeat observations from a previous inspection over seven years ago, highlighting a systemic failure to implement and maintain a compliant quality system.