FDA 483 - Incoba LLC, dba Dynaris - August 19, 2022

Incoba LLC, dba Dynaris, a manufacturer of the Apogee portable oxygen delivery system, was inspected and cited for significant deficiencies across its quality system. The inspection revealed inadequate procedures for medical device reporting, corrective and preventive actions, finished device acceptance, design changes, nonconforming product control, and supplier management. Furthermore, the firm failed to conduct required quality audits for two consecutive years.