FDA Inspection 862161 — Merck Sharp & Dohme Corp.
The FDA completed an inspection of Merck Sharp & Dohme Corp. on December 20, 2013 in Ambler, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 20, 2013
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Ambler, PA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7453 | 21 CFR 312.56(b) | Investigator non-compliance |
| 7482 | 21 CFR 312.50 | General responsibilities of sponsors |
| 7556 | 21 CFR 312.56(b) | Shipments after termination of investigator |