FDA Inspection 1236132 — Biodesix, Inc.
The FDA completed an inspection of Biodesix, Inc. on Apr 12, 2024 in Louisville, CO. 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
- Apr 12, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Louisville, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |