FDA Inspection 1117112 — Norbrook Laboratories Limited
The FDA completed an inspection of Norbrook Laboratories Limited on Feb 7, 2020 in Newry. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 5 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Feb 7, 2020
- Fiscal Year
- 2020
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Newry (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |