FDA Inspection 895238 — Merck Sharp & Dohme LLC
The FDA completed an inspection of Merck Sharp & Dohme LLC on September 12, 2014 in West Point, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 12, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- West Point, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4343 | 21 CFR 211.160(b)(1) | Incoming lots - conformance to written specs- |
| 4353 | 21 CFR 211.160(b)(4) | Instruments, apparatus, et. al. not meeting specs |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |