FDA Inspection 1229927 — Merck Sharp & Dohme LLC
The FDA completed an inspection of Merck Sharp & Dohme LLC on Aug 23, 2024 in West Point, PA. 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: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 23, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- West Point, PA (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 |