FDA Inspection 1167843 — Draeger Medical Systems, Inc.
The FDA completed an inspection of Draeger Medical Systems, Inc. on Apr 21, 2022 in Andover, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 21, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Andover, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |