FDA Inspection
Viatris Inc.Viatris Inc. – FDA Inspection, Apr 12, 2018
Record Details
This FDA Inspection record concerns Viatris Inc., with an inspection on April 12, 2018, issued by the Baltimore District Office, covering human drugs.
- People
- Alison N. Stieg (FDA Associated Person)
- Atul Agrawal (Issuing Officer)
- Ileana Barreto-Pettit (Issuing Officer)
- James M. Mason (Issuing Officer)
- Ko U. Min (FDA Associated Person)
- Marcus A. Ray (FDA Associated Person)
- Melissa T. Roy (FDA Associated Person)
- Rebecca E. Dowd (FDA Associated Person)
View Company Profile
ID · 511517f1-0556-4c7f-b89b-77fc58e3d52e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1047915
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.198(b)(2)Written record of complaint to include findings, follow-up
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Showing 10 of 13 citations.
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.