Company
AustriaSandoz GmbH - Inspection Records
Inspection records and compliance data for Sandoz GmbH in Langkampfen. 7 FDA inspections on record, 1 Form 483, last inspected January 12, 2023.
Company Profile
This profile covers Sandoz GmbH based in Langkampfen, Austria.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 4
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected July 9, 2009. Last inspected January 12, 2023.
Most cited issue areas
- Environmental Monitoring System1 inspection
- Investigations of discrepancies, failures1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 12, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1195376 |
| July 11, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1205998 |
| July 5, 2016 | VAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 981928 |
| March 18, 2014 | NAI | Human Drugs · Drug Quality Assurance | 872125 |
| March 16, 2012 | NAI | Animal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices | 773115 |
| July 29, 2010 | VAI | Human Drugs · Drug Quality Assurance | 678670 |
| July 9, 2009 | NAI | Human Drugs · Drug Quality Assurance | 598994 |
FDA documents
Company Information
Name
Sandoz GmbH
FEI Number
3004828473
Address
Biochemiestrase 10, Langkampfen, Austria
Country
Austria
ID: 02a3eaeb-a765-43ae-873b-93d1d1523696