FDA Inspection
DAVA Pharmaceuticals, Inc.DAVA Pharmaceuticals, Inc. – FDA Inspection, Jul 6, 2012
Record Details
This FDA Inspection record concerns DAVA Pharmaceuticals, Inc., with an inspection on July 6, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- DAVA Pharmaceuticals, Inc.
- Inspection Date
- July 6, 2012
- Product Type
- Drugs
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ID · 03036268-4e22-45fc-9717-3d3b6798d69d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 785247
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 314.81(b)(2)Timely submission
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 314.80(c)(2)Interval
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 314.80(b)Failure to develop written procedures
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Other FDA inspections of DAVA Pharmaceuticals, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 3, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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