1061069
Becton Dickinson Medical Systems — FEI 1000299851
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 1, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Franklin, WI (United States)
Citations
| ID | CFR | Description |
|---|
| 3108 | 21 CFR 820.70(e) | Contamination control, Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |
| 537 | 21 CFR 820.70(a) | Production processes |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |