FDA Inspection 896663 — Alexion Pharmaceuticals, Inc.
The FDA completed an inspection of Alexion Pharmaceuticals, Inc. on September 26, 2014 in New Haven, CT. 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 26, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- New Haven, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 6732 | 21 CFR 314.80(c)(1)(i) | Late submission of 15-day report |
| 6832 | 21 CFR 314.80(c)(2) | Late submission of annual safety reports |