FDA Inspection
Alexion Pharmaceuticals, Inc.Alexion Pharmaceuticals, Inc. – FDA Inspection, Apr 21, 2010
Record Details
This FDA Inspection record concerns Alexion Pharmaceuticals, Inc., with an inspection on April 21, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 21, 2010
- Product Type
- Drugs
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ID · c5f0b310-a869-4517-8ddc-fb7e9100209a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 658294
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 314.80(b)Failure to develop written procedures
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Other FDA inspections of Alexion Pharmaceuticals, Inc.
10| Date | Classification | Office | Project area |
|---|---|---|---|
| August 10, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| August 3, 2017 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| April 19, 2017 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| June 27, 2016 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| June 17, 2015 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Alexion Pharmaceuticals, Inc.
- FDA Inspection 1066184 - 2018-08-10
- FDA Inspection 1024210 - 2017-08-03
- FDA Inspection 1011323 - 2017-04-19
- FDA Inspection 979094 - 2016-06-27
- FDA Inspection 931660 - 2015-06-17
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