FDA Inspection 1005796 — GlaxoWellcome Production
The FDA completed an inspection of GlaxoWellcome Production on Mar 3, 2017 in Evreux. 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). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 3, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Evreux (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |