Company
DenmarkH. Lundbeck A/S, Valby, Denmark – FDA Inspections
Inspection records and compliance data for H. Lundbeck A/S in Valby. 5 FDA inspections on record, 1 Form 483, last inspected December 16, 2022.
Company Profile
This profile covers H. Lundbeck A/S based in Valby, Denmark.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected May 8, 2009. Last inspected December 16, 2022.
Most cited issue areas
- Procedures not in writing, fully followed1 inspection
- Quality control unit review of records1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 16, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1268864 |
| April 27, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1049775 |
| May 6, 2016 | NAI | Human Drugs · Drug Quality Assurance | 973397 |
| June 10, 2013 | NAI | Human Drugs · Drug Quality Assurance | 838375 |
| May 8, 2009 | VAI | Human Drugs · Drug Quality Assurance | 584724 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
H. Lundbeck A/S
FEI Number
3002807185
Address
Ottiliavej 9, Valby, Denmark
Country
Denmark
ID: 4b76a8b4-6579-46ed-84ab-5ad99bb036e5