# FDA 483 - DeVilbiss Healthcare LLC - August 25, 2021

Source: https://www.globalkeysolutions.net/records/483/devilbiss-healthcare-llc/6a09fff4-bdbf-4339-b145-870c92b08760

> FDA 483 for DeVilbiss Healthcare LLC on August 25, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DeVilbiss Healthcare LLC
- Inspection Date: 2021-08-25
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: DeVilbiss Healthcare LLC in Somerset, PA, was cited for significant deficiencies in its quality system, particularly concerning complaint handling, medical device reporting (MDR), and design controls for its 525DS Oxygen Concentrator. The firm failed to adequately establish procedures for receiving and evaluating complaints, properly investigate complaints, and ensure timely MDR submissions. Additionally, design verification was found insufficient, and risk analyses did not accurately reflect product hazards.

## Related Documents

- [WARNING_LETTER - 2021-08-25](https://www.globalkeysolutions.net/records/warning_letter/devilbiss-healthcare-llc/46a0d107-6d0c-4ba6-858d-070e96059985)
- [483 - 2022-08-17](https://www.globalkeysolutions.net/records/483/devilbiss-healthcare-llc/07ae3ff4-cfe8-42f1-abd7-e2175efdbd62)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/dennis-r-hock/f13e2db1-b808-466d-a974-e5af2d5dfdb0)

Company: https://www.globalkeysolutions.net/companies/devilbiss-healthcare-llc/e6ed8b2c-3a4c-4f94-b0c4-6b921f661543

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8