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

Source: https://www.keypedia.com/records/warning_letter/devilbiss-healthcare-llc/46a0d107-6d0c-4ba6-858d-070e96059985

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

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## Details

- Record Type: WARNING_LETTER
- Company Name: DeVilbiss Healthcare LLC
- Inspection Date: 2021-08-25
- Product Type: Devices
- Office Name: Office of Medical Device and Radiological Health Operations (Division 1)
- Summary: The FDA issued a Warning Letter to a medical device manufacturer following an inspection from July 28 to August 25, 2021, at their Somerset, PA facility. The firm manufactures oxygen concentrators, nebulizers, suction units, non-continuous ventilators, and related accessories. The inspection revealed these devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to furnish required information under 21 U.S.C. § 360i and 21 CFR Part 803 (Medical Device Reporting).

Key violations include:
1.  **Design Verification (21 CFR 820.30(f)):** Failure to confirm design outputs meet input requirements. The Model 525 oxygen concentrator uses a compressor operating above its specified ambient temperature range, with inadequate testing to address long-term effects.
2.  **Complaint Handling (21 CFR 820.198(a)):** Failure to maintain complaint files and establish/maintain timely complaint handling procedures. Complaints were not documented promptly (e.g., 73 days late) and not consistently evaluated for Medical Device Reporting (MDR)

## Related Documents

- [483 - 2021-08-25](https://www.keypedia.com/records/483/devilbiss-healthcare-llc/6a09fff4-bdbf-4339-b145-870c92b08760)
- [483 - 2022-08-17](https://www.keypedia.com/records/483/devilbiss-healthcare-llc/07ae3ff4-cfe8-42f1-abd7-e2175efdbd62)

## Related Officers

- [Tony Sapp](https://www.keypedia.com/people/tony-sapp/1e0b1a9a-412d-45f3-80aa-ccfc0172158e)
- [Program Division Director](https://www.keypedia.com/people/joseph-s-matrisciano/62ff5cd6-c3ab-4443-bf26-f61a512f3960)
- [Joseph Lewarski](https://www.keypedia.com/people/joseph-lewarski/648aa9ce-dabc-4608-8fa4-c415c30e2608)

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

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations-division-1/c2b03748-4c7c-4f76-b2ea-bc8f47e6e7f2