Company
SwitzerlandSolvias AG, Kaiseraugst, Switzerland – FDA Inspections
Inspection records and compliance data for Solvias AG in Kaiseraugst. 9 FDA inspections on record, 1 Form 483, last inspected September 01, 2023.
Company Profile
This profile covers Solvias AG based in Kaiseraugst, Switzerland.
FDA Inspection History
- FDA inspections
- 9
- OAI
- 0
- VAI
- 5
- NAI
- 4
- Form 483s
- 1
- Warning letters
- 0
First inspected November 4, 2008. Last inspected September 1, 2023.
Most cited issue areas
- Calibration - at intervals, written program, remedial action1 inspection
- Investigations of discrepancies, failures1 inspection
FDA inspections (9)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 1, 2023 | VAI | Human Drugs · Bioresearch Monitoring | 1219962 |
| June 9, 2023 | NAI | Human Drugs · Drug Quality Assurance | 1210338 |
| November 22, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1193131 |
| October 27, 2017 | NAI | Human Drugs · Drug Quality Assurance | 1036580 |
| March 7, 2014 | VAI | Human Drugs · Drug Quality Assurance | 873203 |
| March 4, 2014 | VAI | Human Drugs · Drug Quality Assurance | 871241 |
| April 8, 2011 | NAI | Human Drugs · Drug Quality Assurance | 729142 |
| June 24, 2010 | VAI | Human Drugs · Drug Quality Assurance | 673196 |
| November 4, 2008 | NAI | Human Drugs · Drug Quality Assurance | 548070 |
FDA documents
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Company Information
Name
Solvias AG
FEI Number
3008735083
Address
Romerpark 2, Kaiseraugst, Switzerland
Country
Switzerland
ID: 3b9382f0-b4d1-46ef-885f-0ccd44ab4d1a