Viatris Pharmaceuticals LLC
⚠️ High Risk
FEI: 2623619 • Vega Baja, PR • UNITED STATES
FEI Number
2623619
Location
Vega Baja, PR
Country
UNITED STATESAddress
Road 689, Km 1.9, , Vega Baja, PR, 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/14/2025 | 61NCY80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | Division of Southeast Imports (DSEI) | |
| 12/2/2024 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 5/5/2023 | 60LCA83CELECOXIB (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/27/2023 | 60LCY83CELECOXIB (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/20/2023 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/30/2021 | 62OCY14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/22/2017 | 56ICA76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/30/2016 | 61JCC08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/2/2014 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | 179AGR RX | San Francisco District Office (SAN-DO) |
| 6/18/2012 | 56ICA76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Viatris Pharmaceuticals LLC's FDA import refusal history?
Viatris Pharmaceuticals LLC (FEI: 2623619) has 10 FDA import refusal record(s) in our database, spanning from 6/18/2012 to 11/14/2025.
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 Pharmaceuticals LLC's FEI number is 2623619.
What types of violations has Viatris Pharmaceuticals LLC received?
Viatris Pharmaceuticals LLC has been cited for 3 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 Pharmaceuticals LLC come from?
All FDA import refusal data for Viatris Pharmaceuticals LLC 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.