FDA Inspection
Sandoz GmbHFDA Inspection 1195376 - Sandoz GmbH - January 12, 2023
Record Details
This FDA Inspection record concerns Sandoz GmbH, with an inspection on January 12, 2023, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 86f9ab67-a44d-428b-83c7-1fbe20ed1b1e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1195376
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sandoz GmbH
6| Date | Classification | Office | Project area |
|---|---|---|---|
| July 11, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 5, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 18, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 16, 2012 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| July 29, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sandoz GmbH
- FDA Inspection 1205998 - 2022-07-11
- FDA Inspection 981928 - 2016-07-05
- FDA Inspection 872125 - 2014-03-18
- FDA Inspection 773115 - 2012-03-16
- FDA Inspection 678670 - 2010-07-29
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.