FDA Inspection
AstraZeneca ABAstraZeneca AB – FDA Inspection, Oct 11, 2018
Record Details
This FDA Inspection record concerns AstraZeneca AB, with an inspection on October 11, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
- People
- James A. Lane (FDA Associated Person)
- Truong X. Nguyen (FDA Associated Person)
- Yong Hu (Issuing Officer)
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ID · d9816a7a-79d6-44ef-a9a7-a7fd466d76ee
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1068727
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of AstraZeneca AB
10| Date | Classification | Office | Project area |
|---|---|---|---|
| April 10, 2026 | Not classified | Office of Inspections and Investigations | |
| November 13, 2025 | NAI | Postmarket Assurance: Devices | |
| December 1, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 6, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 7, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for AstraZeneca AB
- FDA Inspection 1318264 - 2026-04-10
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- FDA Inspection 1248230 - 2022-12-01
- FDA Inspection 1143443 - 2019-12-06
- FDA Inspection 1115572 - 2017-12-07
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