FDA Inspection
Viatris Inc.Viatris Inc. – FDA Inspection, Nov 18, 2016
Record Details
This FDA Inspection record concerns Viatris Inc., with an inspection on November 18, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Atul Agrawal (Issuing Officer)
- Chaltu N.Wakijra (Issuing Officer)
- Massoud Motamed (FDA Associated Person)
- Pratik S. Upadhyay (FDA Associated Person)
View Company Profile
ID · 59e85e46-f095-4a86-9bc9-d0bff7f820e4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 994523
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.198(b)(1)Complaint Record required information
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Other FDA inspections of Viatris Inc.
21| Date | Classification | Office | Project area |
|---|---|---|---|
| August 28, 2026 | Not classified | Baltimore District Office | |
| April 28, 2026 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 18, 2023 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 26, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 15, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Viatris Inc.
- FDA Inspection 1302530 - 2026-08-28
- FDA Inspection 1311680 - 2026-04-28
- FDA Inspection 1219018 - 2023-08-18
- FDA Inspection 1170444 - 2022-05-26
- FDA Inspection 1099590 - 2019-08-15
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