Company
SwitzerlandF. Hoffmann-La Roche AG, Basel Town, Switzerland – FDA Inspections
Inspection records and compliance data for F. Hoffmann-La Roche AG in Basel Town. 10 FDA inspections on record, 2 Form 483s, last inspected November 04, 2024.
Company Profile
This profile covers F. Hoffmann-La Roche AG based in Basel Town, Switzerland.
FDA Inspection History
- FDA inspections
- 10
- OAI
- 0
- VAI
- 4
- NAI
- 4
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected June 25, 2009. Last inspected November 4, 2024.
Most cited issue areas
- Calibration/Inspection/Checking not done1 inspection
- Environmental Monitoring System1 inspection
- Procedures for sterile drug products1 inspection
FDA inspections (10)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 4, 2024 | Not classified | Human Drugs | 1263730 |
| February 16, 2024 | Not classified | Human Drugs | 1234887 |
| January 25, 2024 | NAI | Human Drugs · Bioresearch Monitoring | 1228527 |
| July 27, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1180665 |
| April 24, 2018 | NAI | Human Drugs · Drug Quality Assurance | 1055453 |
| September 23, 2016 | NAI | Human Drugs · Drug Quality Assurance | 990180 |
| March 28, 2014 | VAI | Human Drugs · Drug Quality Assurance | 871865 |
| September 16, 2011 | VAI | Human Drugs · Drug Quality Assurance | 751806 |
| August 28, 2009 | VAI | Human Drugs · Drug Quality Assurance | 615375 |
| June 25, 2009 | NAI | Human Drugs · Drug Quality Assurance | 592222 |
FDA documents
Form 483s (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
F. Hoffmann-La Roche AG
FEI Number
3002807200
Address
Grenzacherstrasse 124/Viaduktrasse 33, Basel Town, Switzerland
Country
Switzerland
ID: 32148dda-fc73-4c59-98ba-f5483a05f328