FDA Inspection 1098340 — Norbrook Laboratories Limited
The FDA completed an inspection of Norbrook Laboratories Limited on July 26, 2019 in Newry. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 26, 2019
- Fiscal Year
- 2019
- Product Type
- Veterinary
- Project Area
- Bioresearch Monitoring
- Location
- Newry (United Kingdom)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 21534 | 21 CFR 514.80(a)(1) | Applicant did not establish/maintain/keep complete safety/effectiveness records |
| 21546 | 21 CFR 514.80(b)(4) | Timely submission of Periodic drug experience report |
| 21551 | 21 CFR 514.80(b)(4)(iv)(B) | Periodic report did not note adverse drug experiences in literature |