Viatris, Inc.
⚠️ High Risk
FEI: 3011055092 • Canonsburg, PA • UNITED STATES
FEI Number
3011055092
Location
Canonsburg, PA
Country
UNITED STATESAddress
1000 Mylan Blvd, , Canonsburg, PA, United States
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/10/2025 | 64GDY29LEVONORGESTREL (ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/24/2025 | 62OCA22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/22/2023 | 62KDH08LOPERAMIDE HYDROCHLORIDE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 7/22/2022 | 62ACK03CALCITONIN, SALMON (ANTI-HYPERCALCEMIC) | Division of Northern Border Imports (DNBI) | |
| 10/8/2020 | 61LDY43PRASUGREL HYDROCHLORIDE (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/4/2018 | 66BCY99STIMULANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/14/2016 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/14/2016 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/9/2015 | 65VCB56ZOLPIDEM TARTRATE (SEDATIVE) | Florida District Office (FLA-DO) | |
| 6/2/2015 | 66JCC01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Viatris, Inc.'s FDA import refusal history?
Viatris, Inc. (FEI: 3011055092) has 10 FDA import refusal record(s) in our database, spanning from 6/2/2015 to 11/10/2025.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Viatris, Inc.'s FEI number is 3011055092.
What types of violations has Viatris, Inc. received?
Viatris, Inc. has been cited for 4 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Viatris, Inc. come from?
All FDA import refusal data for Viatris, Inc. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.