784215
Baxter Healthcare Corporation — FEI 1416980
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 7, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Round Lake, IL (United States)
Citations
| ID | CFR | Description |
|---|
| 14714 | 21 CFR 820.30(c) | Design input - Lack of or inadequate procedures |
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 1852 | 21 CFR 211.94(a) | Reactive/Additive/Absorptive Containers/Closures |
| 2650 | 21 CFR 820.30(f) | Design verification - 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 |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |