FDA Inspection
H. Lundbeck A/SH. Lundbeck A/S – FDA Inspection, Apr 27, 2018
Record Details
This FDA Inspection record concerns H. Lundbeck A/S, with an inspection on April 27, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 7ecbeec9-12e0-4ef9-836e-90b9617866ac
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1049775
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of H. Lundbeck A/S
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 16, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 6, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 10, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 8, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for H. Lundbeck A/S
- FDA Inspection 1268864 - 2022-12-16
- FDA Inspection 973397 - 2016-05-06
- FDA Inspection 838375 - 2013-06-10
- FDA Inspection 584724 - 2009-05-08
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