FDA Inspection
AstraZeneca LPAstraZeneca LP – FDA Inspection, Apr 27, 2016
Record Details
This FDA Inspection record concerns AstraZeneca LP, with an inspection on April 27, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- AstraZeneca LP
- Inspection Date
- April 27, 2016
- Product Type
- Drugs
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ID · 255c25f1-b9cf-4f9d-bd3b-208943e39c98
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 979534
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
1- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
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Other FDA inspections of AstraZeneca LP
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 23, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 14, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 27, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 17, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for AstraZeneca LP
- FDA Inspection 888632 - 2014-07-23
- FDA Inspection 786512 - 2012-06-14
- FDA Inspection 722306 - 2011-04-27
- FDA Inspection 662811 - 2010-05-17
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