FDA Inspection
Alexion Pharma LLCAlexion Pharma LLC – FDA Inspection, Oct 19, 2017
Record Details
This FDA Inspection record concerns Alexion Pharma LLC, with an inspection on October 19, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Rachael L. Derby (Issuing Officer)
View Company Profile
ID · 8a9949de-f890-460c-bfb7-eafe980b5d6f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1029301
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Alexion Pharma LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 16, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 23, 2019 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| August 13, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 10, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 14, 2015 | NAI | Center for Veterinary Medicine | Bioresearch Monitoring |
Other documents for Alexion Pharma LLC
- FDA Inspection 1223315 - 2023-11-16
- FDA Inspection 1113081 - 2019-10-23
- FDA Inspection 941833 - 2015-08-13
- FDA Inspection 941636 - 2015-08-10
- FDA Inspection 927284 - 2015-01-14
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