FDA Inspection 1026576 — Celgene International Sarl
The FDA completed an inspection of Celgene International Sarl on September 15, 2017 in Boudry. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 15, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Boudry (Switzerland)
Citations
| ID | CFR | Description |
|---|---|---|
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |