Roche Products
⚠️ High Risk
FEI: 3002808030 • Welwyn Garden City, Hertfordshire • UNITED KINGDOM
FEI Number
3002808030
Location
Welwyn Garden City, Hertfordshire
Country
UNITED KINGDOMAddress
Hexagon Place, 6 Falcon Way; Shire Park, Welwyn Garden City, Hertfordshire, United Kingdom
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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/20/2024 | 64TDY04MYCOPHENOLATE MOFETIL (IMMUNOSUPPRESSIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/8/2021 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | Division of Southeast Imports (DSEI) | |
| 10/12/2012 | 54AFK18VITAMIN K (PHYTONADIONE) | Division of Southeast Imports (DSEI) | |
| 2/21/2012 | 62IDP99ANTI-NEOPLASTIC N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 9/9/2011 | 61LCP10PHENINDIONE (ANTI-COAGULANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/20/2009 | 62LDB49MEFLOQUINE HYDROCHLORIDE (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/19/2009 | 62VIS31INTERFERON ALFA-2B, RECOMBINANT/RIBAVIRI (ANTI-VIRAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/23/2009 | 62VCH45OSELTAMIVIR PHOSPHATE (ANTI-VIRAL) | Southwest Import District Office (SWI-DO) | |
| 6/23/2009 | 62VCY45OSELTAMIVIR PHOSPHATE (ANTI-VIRAL) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/9/2008 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/28/2005 | 54ABA90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/28/2005 | 64XCB11ISOTRETINOIN (KERATOLYTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Roche Products's FDA import refusal history?
Roche Products (FEI: 3002808030) has 12 FDA import refusal record(s) in our database, spanning from 6/28/2005 to 9/20/2024.
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. Roche Products's FEI number is 3002808030.
What types of violations has Roche Products received?
Roche Products has been cited for 6 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 Roche Products come from?
All FDA import refusal data for Roche Products 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.