FDA Inspection
Sandoz IncorporatedSandoz Incorporated – FDA Inspection, Apr 16, 2019
Record Details
This FDA Inspection record concerns Sandoz Incorporated, with an inspection on April 16, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 1753bbcb-38cd-4266-b013-2cf283d256a3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1087173
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Sandoz Incorporated
7| Date | Classification | Office | Project area |
|---|---|---|---|
| March 29, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 30, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 17, 2013 | VAI | Center for Drug Evaluation and Research | Postmarket Surv. and Epidemiology |
| August 14, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 6, 2011 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sandoz Incorporated
- FDA Inspection 1013036 - 2017-03-29
- FDA Inspection 981954 - 2015-10-30
- FDA Inspection 853190 - 2013-10-17
- FDA Inspection 797878 - 2012-08-14
- FDA Inspection 727431 - 2011-05-06
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