FDA Inspection 809344 — ICU Medical, Inc.
The FDA completed an inspection of ICU Medical, Inc. on November 30, 2012 in Salt Lake City, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 30, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Salt Lake City, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3434 | 21 CFR 820.75(c) | Documentation - review in response to changes or deviations |
| 3837 | 21 CFR 820.25(b) | Training records |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |