FDA Inspection
Alexion Pharmaceuticals, Inc.Alexion Pharmaceuticals, Inc. – FDA Inspection, Aug 22, 2014
Record Details
This FDA Inspection record concerns Alexion Pharmaceuticals, Inc., with an inspection on August 22, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 22, 2014
- Product Type
- Drugs
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ID · 1fe0988b-1aa2-498c-a4f8-2a4f55398a0c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 892913
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Alexion Pharmaceuticals, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 21, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 3, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 12, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 18, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Alexion Pharmaceuticals, Inc.
- FDA Inspection 1019062 - 2017-07-21
- FDA Inspection 984855 - 2016-08-03
- FDA Inspection 938440 - 2015-08-12
- FDA Inspection 710477 - 2011-02-18
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