FDA Inspection
AstraZeneca ABAstraZeneca AB – FDA Inspection, Feb 7, 2017
Record Details
This FDA Inspection record concerns AstraZeneca AB, with an inspection on February 7, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 498c9706-b91b-4dc9-803c-346446861c6b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1010067
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.87Retest of approved components/containers/closures
- 21 CFR 211.132(b)(1)OTC products requiring tamper-evident packaging
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Other FDA inspections of AstraZeneca AB
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|---|---|---|---|
| December 1, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 11, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 30, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 26, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 29, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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