FDA Inspection 1070336 — Merck Sharp & Dohme LLC
The FDA completed an inspection of Merck Sharp & Dohme LLC on October 30, 2018 in Durham, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 30, 2018
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Durham, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 9086 | 21 CFR 600.14(a)(1) | Who must report - manufacturer |