FDA 483 - Rapid Oxygen Inc. - April 26, 2024

Rapid Oxygen Inc. in Shelton, CT, was inspected by the FDA, resulting in four observations. The inspection revealed significant deficiencies in the firm's quality system, including inadequate corrective and preventive action procedures, poorly maintained device history records, and insufficient incoming product acceptance procedures. Additionally, the firm lacked documentation for process revalidation following a facility relocation.