FDA Inspection
LEO Pharma IrelandLEO Pharma Ireland – FDA Inspection, Jun 24, 2022
Record Details
This FDA Inspection record concerns LEO Pharma Ireland, with an inspection on June 24, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- LEO Pharma Ireland
- Inspection Date
- June 24, 2022
- Product Type
- Drugs
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ID · e59e55dd-779a-4596-8c8a-44a8502783d9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1172983
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.48(a)Plumbing System Defects
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Other FDA inspections of LEO Pharma Ireland
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 3, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 14, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 9, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 8, 2008 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for LEO Pharma Ireland
- FDA Inspection 1032319 - 2017-11-03
- FDA Inspection 877763 - 2014-03-14
- FDA Inspection 745395 - 2011-09-09
- FDA Inspection 556572 - 2008-12-08
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