Company
SwedenAstraZeneca AB, Sodertalje, Sweden – FDA Inspections
Inspection records and compliance data for AstraZeneca AB in Sodertalje. 8 FDA inspections on record, 2 Form 483s, last inspected December 01, 2022.
Company Profile
This profile covers AstraZeneca AB based in Sodertalje, Sweden.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 4
- NAI
- 4
- Form 483s
- 2
- Warning letters
- 0
First inspected March 19, 2010. Last inspected December 1, 2022.
Most cited issue areas
- OTC products requiring tamper-evident packaging1 inspection
- Retest of approved components/containers/closures1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 1, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1248349 |
| October 11, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1124752 |
| August 30, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1102604 |
| February 7, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1010067 |
| September 26, 2014 | NAI | Human Drugs · Drug Quality Assurance | 897789 |
| May 29, 2012 | NAI | Human Drugs · Drug Quality Assurance | 853188 |
| December 9, 2010 | NAI | Human Drugs · Drug Quality Assurance | 724676 |
| March 19, 2010 | NAI | Human Drugs · Drug Quality Assurance | 654557 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
AstraZeneca AB
FEI Number
3002806411
Address
Forskargatan 18 Se-151 36, Sodertalje, Sweden
Country
Sweden
ID: 46419837-c081-4920-b360-9adb4b9bf329