FDA Inspection
Novartis Pharmaceuticals A. G.Novartis Pharmaceuticals A. G. – FDA Inspection, Mar 23, 2017
Record Details
This FDA Inspection record concerns Novartis Pharmaceuticals A. G., with an inspection on March 23, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Jamie L. Dion (Issuing Officer)
- Tenzin Jangchup (FDA Associated Person)
View Company Profile
ID · e00ca04c-fa6a-4cd3-be80-cea0ec862f62
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1009385
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 314.80(c)(1)(iii)Non-applicant reports directly to FDA
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