FDA WARNING_LETTER - DeVilbiss Healthcare LLC - August 25, 2021

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)