FDA Inspection 1086693 — Norbrook Laboratories Limited
The FDA completed an inspection of Norbrook Laboratories Limited on Apr 18, 2019 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
- Apr 18, 2019
- Fiscal Year
- 2019
- Product Type
- Veterinary
- Project Area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Location
- Newry (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |