The Oxygen Therapy Institute was hit with a Form 483 for inadequate acceptance procedures, calibration procedures, and other deficiencies.
Following an October 2016 visit to the company’s Jacksonville, Fla., facility, FDA inspectors observed that procedures for acceptance activities were not adequately established. For example, the delivery pressure for an oxygen inhaler unit was not verified, the firm had no established acceptance procedures for components used in its convenience kits or for the kits themselves, and the institute lacked verification documents for components and functions of the unit. For example, there was no documentation to confirm that oxygen was flowing to the mask.
The FDA also cited inadequate procedures to ensure that all products and services conformed to specified requirements. In addition, it said Oxygen Therapy had no calibration procedure for test equipment, such as gauges for testing regulators used in its inhaler units.
Further observations included that the firm lacked internal audit procedures and had not conducted internal quality audits; had not documented complaints and lacked a written procedure for handling them; and had not established procedures to control non-conforming products, conduct corrective and preventive actions, or file medical device reports.