H. Lundbeck A/S — FDA Facility Profile
H. Lundbeck A/S is an FDA-registered facility (FEI 3002807185) located in Valby, DK. Registered operations: ANALYSIS; MANUFACTURE; PACK. RegDataLab tracks 5 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Dec 16, 2022: Voluntary Action Indicated (VAI)
- Inspections on record
- 5 (3 VAI, 2 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Import refusals
- 10 or more
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Dec 16, 2022 | Voluntary Action Indicated (VAI) | No citations listed |
| Apr 27, 2018 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Quality control unit review of records (21 CFR 211.192) |
| May 6, 2016 | No Action Indicated (NAI) | No citations listed |
| Jun 10, 2013 | No Action Indicated (NAI) | No citations listed |
| May 8, 2009 | Voluntary Action Indicated (VAI) | No citations listed |
Facility details
- Company
- H. Lundbeck A/S
- Location
- Valby (DK)
- Registration Expires
- Dec 31, 2026
- Operations
- ANALYSIS; MANUFACTURE; PACK
- Source
- decrs