FDA Inspection 1140222 — Merck Sharp & Dohme LLC
The FDA completed an inspection of Merck Sharp & Dohme LLC on April 16, 2021 in Durham, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 16, 2021
- Fiscal Year
- 2021
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Durham, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |