FDA Inspection 772201 — Albert Browne Ltd.
The FDA completed an inspection of Albert Browne Ltd. on March 1, 2012 in Leicester. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 1, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Leicester (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3190 | 21 CFR 820.30(g) | Design validation acceptance criteria |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 3270 | 21 CFR 820.80(c) | Documentation |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |