Troge Medical Gmbh
⚠️ Moderate Risk
FEI: 3001061178 • Hamburg, Hamburg • GERMANY
FEI Number
3001061178
Location
Hamburg, Hamburg
Country
GERMANYAddress
Milchstr. 19, 13, Hamburg, Hamburg, 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).
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 |
|---|---|---|---|
| 3/23/2017 | 61HCO99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56BCK52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 61HCO99ANTI-BACTERIAL, N.E.C. | New Orleans District Office (NOL-DO) | |
| 11/15/2011 | 79KCECANNULAE, BRONCHIAL | Division of Southeast Imports (DSEI) | |
| 11/15/2011 | 74DYGCATHETER, FLOW DIRECTED | Division of Southeast Imports (DSEI) | |
| 9/9/2011 | 56DCK21GENTAMICIN SULFATE (AMINOGLYCOSIDES) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/9/2011 | 56DCZ99AMINOGLYCOSIDES, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/9/2011 | 56CCZ70CEFTRIAXONE SODIUM (CEPHALOSPORINS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/9/2011 | 56ICK35ERYTHROMYCIN STEARATE (MACROLIDES) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/9/2011 | 56BCZ03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/9/2011 | 56BCZ03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/9/2011 | 56YCO99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Troge Medical Gmbh's FDA import refusal history?
Troge Medical Gmbh (FEI: 3001061178) has 12 FDA import refusal record(s) in our database, spanning from 9/9/2011 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. Troge Medical Gmbh's FEI number is 3001061178.
What types of violations has Troge Medical Gmbh received?
Troge Medical Gmbh has been cited for 3 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 Troge Medical Gmbh come from?
All FDA import refusal data for Troge Medical 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.