FDA Inspection
Norbrook Laboratories LimitedNorbrook Laboratories Limited – FDA Inspection, Feb 7, 2020
Record Details
This FDA Inspection record concerns Norbrook Laboratories Limited, with an inspection on February 7, 2020, issued by the Center for Veterinary Medicine, covering veterinary.
- Inspection Date
- February 7, 2020
- Product Type
- Veterinary
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ID · 945caab8-0b46-4fe0-b88e-bdbd918906e1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1117113
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
6- 21 CFR 211.68(b)Backup data not assured as exact and complete
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.101(d)Component addition checked by 2nd person
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.100(a)Approval and review of procedures
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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 |
| July 26, 2019 | VAI | Center for Veterinary Medicine | Pre-Approval Eval. of Animal Drugs and Food Additives |
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 1098340 - 2019-07-26
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