FDA Inspection 904900 — Cardiovascular Systems Inc
The FDA completed an inspection of Cardiovascular Systems Inc on Oct 24, 2014 in Saint Paul, MN. 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
- Oct 24, 2014
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Saint Paul, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3674 | 21 CFR 820.30(d) | Design output - documentation |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |