FDA Inspection
Leo Pharma IncLeo Pharma Inc – FDA Inspection, Sep 19, 2014
Record Details
This FDA Inspection record concerns Leo Pharma Inc, with an inspection on September 19, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Leo Pharma Inc
- Inspection Date
- September 19, 2014
- Product Type
- Drugs
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ID · add96b2d-3c2f-4495-b531-dfd5fece5236
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 897087
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 314.80(b)Failure to develop written procedures
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Other FDA inspections of Leo Pharma Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 20, 2013 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Leo Pharma Inc
- FDA Inspection 832454 - 2013-05-20
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