FDA Inspection 1094564 — Merck Sharp & Dohme LLC
The FDA completed an inspection of Merck Sharp & Dohme LLC on June 28, 2019 in Elkton, VA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 28, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Elkton, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1266 | 21 CFR 211.42(d) | Penicillin processing area not kept separate |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |