FDA Inspection
Lundbeck Pharmaceuticals Italy S.p.A.Lundbeck Pharmaceuticals Italy S.p.A. – FDA Inspection, May 12, 2017
Record Details
This FDA Inspection record concerns Lundbeck Pharmaceuticals Italy S.p.A., with an inspection on May 12, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 56d2e2bc-4caf-4561-a73b-1b9b233c2684
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1012792
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Lundbeck Pharmaceuticals Italy S.p.A.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 25, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 17, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 28, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 13, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Lundbeck Pharmaceuticals Italy S.p.A.
- FDA Inspection 1179248 - 2022-03-25
- FDA Inspection 924724 - 2015-04-17
- FDA Inspection 801925 - 2012-09-28
- FDA Inspection 575028 - 2009-03-13
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