Company
SwedenAstraZeneca AB, Sodertalje, Sweden – FDA Inspections
Inspection records and compliance data for AstraZeneca AB in Sodertalje. 11 FDA inspections on record, 2 Form 483s, last inspected April 10, 2026.
Company Profile
This profile covers AstraZeneca AB based in Sodertalje, Sweden.
FDA Inspection History
- FDA inspections
- 11
- OAI
- 0
- VAI
- 6
- NAI
- 4
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected March 25, 2010. Last inspected April 10, 2026.
Most cited issue areas
- Procedures not in writing, fully followed1 inspection
FDA inspections (11)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 10, 2026 | Not classified | Human Drugs | 1318264 |
| November 13, 2025 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1295446 |
| December 1, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1248230 |
| December 6, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1143443 |
| October 11, 2018 | VAI | Human Drugs · New Drug Evaluation | 1068727 |
| December 7, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1115572 |
| January 27, 2017 | NAI | Human Drugs · Drug Quality Assurance | 1007887 |
| March 28, 2014 | VAI | Human Drugs · Drug Quality Assurance | 877076 |
| May 29, 2012 | NAI | Human Drugs · Drug Quality Assurance | 801077 |
| December 10, 2010 | VAI | Human Drugs · Drug Quality Assurance | 724900 |
| March 25, 2010 | NAI | Human Drugs · Drug Quality Assurance | 654554 |
FDA documents
Form 483s (1)
Other FDA documents (1)
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
AstraZeneca AB
FEI Number
3003342394
Address
Gartunavagen, Sodertalje, Sweden
Country
Sweden
ID: b85a1aa5-9a0c-4c1e-996d-70b40b2507de