FDA Inspection 795318 — Alexion Pharmaceuticals, Inc.
The FDA completed an inspection of Alexion Pharmaceuticals, Inc. on August 17, 2012 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 17, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- New Haven, CT (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 2618 | 21 CFR 211.198(b)(1) | Complaint Record required information |