FDA Inspection
AstraZeneca Pharmaceuticals LPAstraZeneca Pharmaceuticals LP – FDA Inspection, Sep 19, 2023
Record Details
This FDA Inspection record concerns AstraZeneca Pharmaceuticals LP, with an inspection on September 19, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f66f66c2-0f6a-4aa1-972a-c17574142886
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1218331
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.110(a)Written in-process control procedures
- 21 CFR 211.110(a)Written in-process control procedures
- 21 CFR 211.194(a)(4)Complete Test Data
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Other FDA inspections of AstraZeneca Pharmaceuticals LP
7| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| October 28, 2011 | VAI | 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 965123 - 2016-01-28
- FDA Inspection 853863 - 2013-10-25
- FDA Inspection 798609 - 2012-09-13
- FDA Inspection 751470 - 2011-10-28
- FDA Inspection 741276 - 2011-08-12
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