FDA Inspection
Merck Sharp & Dohme Corp.Merck Sharp & Dohme Corp. – FDA Inspection, Aug 31, 2009
Record Details
This FDA Inspection record concerns Merck Sharp & Dohme Corp., with an inspection on August 31, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Merck Sharp & Dohme Corp.
- Inspection Date
- August 31, 2009
- Product Type
- Drugs
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ID · 4ca7049c-17d3-40fb-9fbc-83a856677875
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 608234
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Merck Sharp & Dohme Corp.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 4, 2014 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| July 10, 2014 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| August 20, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 26, 2013 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| December 9, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Merck Sharp & Dohme Corp.
- FDA Inspection 893844 - 2014-09-04
- FDA Inspection 886651 - 2014-07-10
- FDA Inspection 845280 - 2013-08-20
- FDA Inspection 823433 - 2013-03-26
- FDA Inspection 754086 - 2011-12-09
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