Rottendorf Pharma Gmbh
⚠️ High Risk
FEI: 3003732290 • Ennigerloh, North Rhine-Westphalia • GERMANY
FEI Number
3003732290
Location
Ennigerloh, North Rhine-Westphalia
Country
GERMANYAddress
Ostenfelder Str. 51-61, , Ennigerloh, North Rhine-Westphalia, Germany
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/25/2025 | 61PCY73EMPAGLIFLOZIN (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 8/13/2025 | 61PCA73EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/25/2025 | 61PDY73EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/11/2025 | 61PCY73EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 6/13/2025 | 61PDY73EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 61PDY73EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/21/2025 | 61PCY73EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/17/2024 | 61PDY73EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/2/2024 | 61PDY73EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/14/2024 | 61PDY73EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/18/2024 | 62ODY09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | Division of Southeast Imports (DSEI) | |
| 2/29/2024 | 62TDY06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/1/2023 | 61PDA73EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/8/2021 | 65ACA04MEMANTINE HCI | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/18/2017 | 64USA99INHIBITOR N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 10/18/2017 | 64USA99INHIBITOR N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 10/18/2017 | 64USA99INHIBITOR N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Rottendorf Pharma Gmbh's FDA import refusal history?
Rottendorf Pharma Gmbh (FEI: 3003732290) has 17 FDA import refusal record(s) in our database, spanning from 10/18/2017 to 11/25/2025.
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. Rottendorf Pharma Gmbh's FEI number is 3003732290.
What types of violations has Rottendorf Pharma Gmbh received?
Rottendorf Pharma Gmbh has been cited for 2 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 Rottendorf Pharma Gmbh come from?
All FDA import refusal data for Rottendorf Pharma Gmbh 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.