FDA Inspection 599345 — Draeger Medical Systems, Inc.
The FDA completed an inspection of Draeger Medical Systems, Inc. on Jul 9, 2009 in Telford, PA. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 9, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Telford, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |