Roche Pharma AG
⚠️ Moderate Risk
FEI: 3002807206 • Grenzach-Wyhlen, Baden-Wurttemberg • GERMANY
FEI Number
3002807206
Location
Grenzach-Wyhlen, Baden-Wurttemberg
Country
GERMANYAddress
Emil-Barell-Str. 1, , Grenzach-Wyhlen, Baden-Wurttemberg, Germany
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/20/2018 | 62VIK55PEGINTERFERON ALFA-2A | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 5/28/2009 | 62VAE45OSELTAMIVIR PHOSPHATE (ANTI-VIRAL) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/9/2008 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Roche Pharma AG's FDA import refusal history?
Roche Pharma AG (FEI: 3002807206) has 3 FDA import refusal record(s) in our database, spanning from 5/9/2008 to 2/20/2018.
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 Pharma AG's FEI number is 3002807206.
What types of violations has Roche Pharma AG received?
Roche Pharma AG has been cited for 1 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 Pharma AG come from?
All FDA import refusal data for Roche Pharma 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.