793071
ICU Medical, Inc. — FEI 3013319212
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 13, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Lake Forest, IL (United States)
Citations
| ID | CFR | Description |
|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 3198 | 21 CFR 820.40(b) | Document changes, review and approval, communication |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4197 | 21 CFR 806.10(c)(4) | Device marketing status |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |
| 751 | 21 CFR 803.52(b)(5) | Description of the Event or Problem |