FDA Inspection 723101 — Merck & Co., Inc.
The FDA completed an inspection of Merck & Co., Inc. on May 6, 2011 in Springfield, 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 6, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Springfield, NJ (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7482 | 21 CFR 312.50 | General responsibilities of sponsors |
| 7483 | 21 CFR 312.55(b) | New observations, adverse effects and risks |