FDA Inspection
Norbrook Laboratories LimitedNorbrook Laboratories Limited – FDA Inspection, Apr 18, 2019
Record Details
This FDA Inspection record concerns Norbrook Laboratories Limited, with an inspection on April 18, 2019, issued by the Office of Inspections and Investigations, covering animal drugs & feeds.
- Person
- Ileana Barreto-Pettit (Issuing Officer)
View Company Profile
ID · c75949f6-c5d4-46eb-bf21-87cd5fd5b3d3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1086693
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Norbrook Laboratories Limited
14| Date | Classification | Office | Project area |
|---|---|---|---|
| June 5, 2026 | Not classified | Office of Inspections and Investigations | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| April 4, 2025 | Not classified | Office of Inspections and Investigations | Monitoring of Marketed Animal Drugs, Feeds, and Devices |
| March 29, 2024 | OAI | Center for Veterinary Medicine | Pre-Approval Eval. of Animal Drugs and Food Additives |
| October 15, 2021 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| February 7, 2020 | OAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Norbrook Laboratories Limited
- FDA Inspection 1321402 - 2026-06-05
- FDA Inspection 1266165 - 2025-04-04
- FDA Inspection 1236307 - 2024-03-29
- FDA Inspection 1155086 - 2021-10-15
- FDA Inspection 1117113 - 2020-02-07
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.