FDA Inspection 821451 — Sterex Electrolysis Int Ltd
The FDA completed an inspection of Sterex Electrolysis Int Ltd on February 14, 2013 in Birmingham. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 14, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Birmingham (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3266 | 21 CFR 820.86 | Acceptance status |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |