Rotexmedica Gmbh
⚠️ Moderate Risk
FEI: 3001181311 • Trittau, Schleswig-Holstein • GERMANY
FEI Number
3001181311
Location
Trittau, Schleswig-Holstein
Country
GERMANYAddress
Bunsenstr. 4, , Trittau, Schleswig-Holstein, 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).
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 |
|---|---|---|---|
| 3/23/2017 | 60QCP67LIDOCAINE (ANESTHETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 60QCP67LIDOCAINE (ANESTHETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 60QCP67LIDOCAINE (ANESTHETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 60QCP67LIDOCAINE (ANESTHETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56DCP20GENTAMICIN (AMINOGLYCOSIDES) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 62GCP18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | New Orleans District Office (NOL-DO) | |
| 4/24/2007 | 60QCP67LIDOCAINE (ANESTHETIC) | New Orleans District Office (NOL-DO) | |
| 4/24/2007 | 64LCO37HYDROCORTISONE (GLUCOCORTICOID) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Rotexmedica Gmbh's FDA import refusal history?
Rotexmedica Gmbh (FEI: 3001181311) has 8 FDA import refusal record(s) in our database, spanning from 4/24/2007 to 3/23/2017.
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. Rotexmedica Gmbh's FEI number is 3001181311.
What types of violations has Rotexmedica Gmbh received?
Rotexmedica 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 Rotexmedica Gmbh come from?
All FDA import refusal data for Rotexmedica 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.