Company
SwitzerlandF. Hoffmann - La Roche Ltd., Kaiseraugst, Switzerland – FDA Inspections
Inspection records and compliance data for F. Hoffmann - La Roche Ltd. in Kaiseraugst. 9 FDA inspections on record, 2 Form 483s, last inspected November 04, 2024.
Company Profile
This profile covers F. Hoffmann - La Roche Ltd. based in Kaiseraugst, Switzerland.
FDA Inspection History
- FDA inspections
- 9
- OAI
- 0
- VAI
- 6
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected July 2, 2009. Last inspected November 4, 2024.
Most cited issue areas
- Investigations of discrepancies, failures2 inspections
- Acceptable supplier records, inadequate records1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
FDA inspections (9)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 4, 2024 | Not classified | Human Drugs | 1265000 |
| August 5, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1177103 |
| May 4, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1051581 |
| September 13, 2016 | VAI | Human Drugs · Drug Quality Assurance | 990453 |
| January 21, 2016 | NAI | Human Drugs · Drug Quality Assurance | 963013 |
| April 8, 2014 | VAI | Human Drugs · Drug Quality Assurance | 878377 |
| July 25, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 844683 |
| July 29, 2011 | NAI | Human Drugs · Drug Quality Assurance | 740525 |
| July 2, 2009 | VAI | Human Drugs · Drug Quality Assurance | 604815 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
F. Hoffmann - La Roche Ltd.
FEI Number
3003973536
Address
Wurmisweg, Kaiseraugst, Switzerland
Country
Switzerland
ID: 622e8fa3-95f3-4ed9-a1bd-99dc0748f273