FDA Inspection 955689 — Merck & Co. Inc
The FDA completed an inspection of Merck & Co. Inc on Nov 19, 2015 in Rahway, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 19, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Rahway, NJ (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7480 | 21 CFR 312.50 | Ensuring compliance with plan and protocol |
| 7482 | 21 CFR 312.50 | General responsibilities of sponsors |
| 7558 | 21 CFR 312.57(c) | Record retention requirement |