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

Source: https://www.keypedia.com/records/483/incoba-llc-dba-dynaris/2688e47d-353f-4f5d-86c5-05696c0a2f19

> FDA 483 for Incoba LLC, dba Dynaris on August 19, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Incoba LLC, dba Dynaris
- Inspection Date: 2022-08-19
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: 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.

## Related Officers

- [Edward E. Lockwood](https://www.keypedia.com/people/edward-e-lockwood/3260b39e-9211-489f-8247-0ec3353e57ca)

Company: https://www.keypedia.com/companies/incoba-llc-dba-dynaris/c41d4106-4c9f-4fc6-b01e-048d508d5e1a

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8