F. Hoffmann-La Roche AG
⚠️ High Risk
FEI: 3002807200 • Basel Town, Basel Town • SWITZERLAND
FEI Number
3002807200
Location
Basel Town, Basel Town
Country
SWITZERLANDAddress
Grenzacherstrasse 124/Viaduktrasse 33, , Basel Town, Basel Town, Switzerland
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
RX LEGEND
The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
NO LICENSE
The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/14/2025 | 58MCL03TOCILIZUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/14/2025 | 58MCL03TOCILIZUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 58MCL03TOCILIZUMAB | Division of Southeast Imports (DSEI) | |
| 8/31/2021 | 61HAY03TRIMETHOPRIM (ANTI-BACTERIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/24/2016 | 66MDY75BROMAZEPAM (TRANQUILIZER) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/16/2016 | 55RY55SODIUM CHLORIDE (PHARMACEUTIC NECESSITY - TONICITY AGENT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/9/2014 | 62ICS99ANTI-NEOPLASTIC N.E.C. | 16DIRECTIONS | Detroit District Office (DET-DO) |
| 12/12/2012 | 62ICS99ANTI-NEOPLASTIC N.E.C. | Detroit District Office (DET-DO) | |
| 4/30/2012 | 62OIY22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/13/2012 | 62ICK99ANTI-NEOPLASTIC N.E.C. | New Orleans District Office (NOL-DO) | |
| 4/2/2012 | 65VCC15DIAZEPAM (SEDATIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2012 | 62VBE45OSELTAMIVIR PHOSPHATE (ANTI-VIRAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/14/2011 | 88KJGTUBE, TISSUE CULTURE | New York District Office (NYK-DO) | |
| 6/11/2011 | 80MWVNEEDLES, MEDICAMENT DISPENSING TIP & IRRIGATING | 341REGISTERED | New York District Office (NYK-DO) |
| 2/25/2011 | 66VBS99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/14/2009 | 62VIP31INTERFERON ALFA-2B, RECOMBINANT/RIBAVIRI (ANTI-VIRAL) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 6/3/2009 | 62VBA45OSELTAMIVIR PHOSPHATE (ANTI-VIRAL) | Los Angeles District Office (LOS-DO) | |
| 4/4/2007 | 57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 71NO LICENSE | San Francisco District Office (SAN-DO) |
| 5/2/2006 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 4/17/2006 | 62OCY12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 1/11/2006 | 62VDC45OSELTAMIVIR PHOSPHATE (ANTI-VIRAL) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 9/13/2005 | 64XCC11ISOTRETINOIN (KERATOLYTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/18/2005 | 64XCB11ISOTRETINOIN (KERATOLYTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/18/2005 | 64XCC11ISOTRETINOIN (KERATOLYTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/28/2005 | 60RAB18ORLISTAT/TETRAHYDROLIPSTATIN (ANOREXIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/13/2005 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/24/2005 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/3/2004 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/4/2004 | 62VCL45OSELTAMIVIR PHOSPHATE (ANTI-VIRAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/29/2002 | 64LCS26FLUNISOLIDE (GLUCOCORTICOID) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 8/6/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is F. Hoffmann-La Roche AG's FDA import refusal history?
F. Hoffmann-La Roche AG (FEI: 3002807200) has 31 FDA import refusal record(s) in our database, spanning from 8/6/2002 to 4/14/2025.
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. F. Hoffmann-La Roche AG's FEI number is 3002807200.
What types of violations has F. Hoffmann-La Roche AG received?
F. Hoffmann-La Roche AG has been cited for 8 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 F. Hoffmann-La Roche AG come from?
All FDA import refusal data for F. Hoffmann-La Roche AG 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.