925591
ICU Medical, Inc. — FEI 3013319212
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 27, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lake Forest, IL (United States)
Citations
| ID | CFR | Description |
|---|
| 14719 | 21 CFR 820.30(h) | Incorrect translation to production specifications |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3686 | 21 CFR 820.90(b)(2) | Product rework documentation, DHR {see also 820.184} |