FDA Inspection 917872 — Merck & Co. Inc
The FDA completed an inspection of Merck & Co. Inc on February 23, 2015 in Rahway, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 23, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Rahway, NJ (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7461 | 21 CFR 312.58(a) | FDA access to sponsor records |
| 7482 | 21 CFR 312.50 | General responsibilities of sponsors |