FDA Inspection 988733 — Vertex Pharmaceuticals Incorporated
The FDA completed an inspection of Vertex Pharmaceuticals Incorporated on September 21, 2016 in Boston, MA. 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
- September 21, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Boston, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |