FDA Inspection
Viatris Inc.Viatris Inc. – FDA Inspection, Jul 25, 2019
Record Details
This FDA Inspection record concerns Viatris Inc., with an inspection on July 25, 2019, issued by the Baltimore District Office, covering human drugs.
View Company Profile
ID · 73c177da-f9fd-4e65-a8aa-55745cfaf565
Inspection Facts
- Inspection number
- 1097589
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.67(b)Written procedures not established/followed
Full citation text and observation details available on the Dashboard.
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
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.