Company
United KingdomNorgine Limited, Hengoed, United Kingdom – FDA Inspections
Inspection records and compliance data for Norgine Limited in Hengoed. 3 FDA inspections on record, 3 Form 483s, last inspected June 20, 2025.
Company Profile
This profile covers Norgine Limited based in Hengoed, United Kingdom.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 3
- Warning letters
- 0
First inspected September 8, 2017. Last inspected June 20, 2025.
Most cited issue areas
- Acceptance of drug products1 inspection
- Cleaning / Sanitizing / Maintenance1 inspection
- Component identification test1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 20, 2025 | VAI | Human Drugs · Drug Quality Assurance | 1273643 |
| August 16, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1099809 |
| September 8, 2017 | Not classified | Human Drugs | 1028723 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Other regulators (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Norgine Limited
FEI Number
3005202761
Address
7 Tir Y Berth Industrial Estate, New Road, Hengoed, United Kingdom
Country
United Kingdom
ID: f5bbd901-c616-4a8b-86d3-1a8b4c902e24