FDA Inspection
Elan Pharmaceuticals, Inc.Elan Pharmaceuticals, Inc. – FDA Inspection, Sep 15, 2009
Record Details
This FDA Inspection record concerns Elan Pharmaceuticals, Inc., with an inspection on September 15, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Elan Pharmaceuticals, Inc.
- Inspection Date
- September 15, 2009
- Product Type
- Drugs
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ID · 63c82b76-5ee3-4751-a6bb-5289fedd52b1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 611599
- 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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