FDA Inspection
AstraZeneca Pharmaceuticals LPAstraZeneca Pharmaceuticals LP – FDA Inspection, Oct 28, 2011
Record Details
This FDA Inspection record concerns AstraZeneca Pharmaceuticals LP, with an inspection on October 28, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 28, 2011
- Product Type
- Drugs
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ID · 5d401b01-20f7-49dd-b629-fc4aeae2f2cf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 751470
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.110(a)Written in-process control procedures
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Other FDA inspections of AstraZeneca Pharmaceuticals LP
7| Date | Classification | Office | Project area |
|---|---|---|---|
| September 19, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 28, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 25, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 13, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 12, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for AstraZeneca Pharmaceuticals LP
- FDA Inspection 1218331 - 2023-09-19
- FDA Inspection 965123 - 2016-01-28
- FDA Inspection 853863 - 2013-10-25
- FDA Inspection 798609 - 2012-09-13
- FDA Inspection 741276 - 2011-08-12
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