FDA Inspection
Merck Sharp & Dohme Corp.Merck Sharp & Dohme Corp. – FDA Inspection, Dec 20, 2013
Record Details
This FDA Inspection record concerns Merck Sharp & Dohme Corp., with an inspection on December 20, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Merck Sharp & Dohme Corp.
- Inspection Date
- December 20, 2013
- Product Type
- Drugs
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ID · 775d5953-f8bc-4984-a142-f6d86192b451
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 862161
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 312.56(b)Investigator non-compliance
- 21 CFR 312.56(b)Shipments after termination of investigator
- 21 CFR 312.50General responsibilities of sponsors
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Other FDA inspections of Merck Sharp & Dohme Corp.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 27, 2013 | OAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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