FDA Inspection
Sandoz GmbHFDA Inspection 981928 - Sandoz GmbH - July 05, 2016
Record Details
This FDA Inspection record concerns Sandoz GmbH, with an inspection on July 5, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Sandoz GmbH
- Inspection Date
- July 5, 2016
- Product Type
- Drugs
View Company Profile
ID · e244ae75-1574-4c09-a0a1-018410843080
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 981928
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.80(a)Procedures To Be in Writing
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Other FDA inspections of Sandoz GmbH
6| Date | Classification | Office | Project area |
|---|---|---|---|
| January 12, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 11, 2022 | 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 1195376 - 2023-01-12
- FDA Inspection 1205998 - 2022-07-11
- FDA Inspection 872125 - 2014-03-18
- FDA Inspection 773115 - 2012-03-16
- FDA Inspection 678670 - 2010-07-29
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