Transo-Pharm Handels GMBH
⚠️ Moderate Risk
FEI: 3003773765 • Siek, Schleswig-Holstein • GERMANY
FEI Number
3003773765
Location
Siek, Schleswig-Holstein
Country
GERMANYAddress
Bultbek 5, , Siek, 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
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
DR QUALITC
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/10/2014 | 60NCS06NANDROLONE DECANOATE (ANDROGEN) | 27DRUG GMPS | Southwest Import District Office (SWI-DO) |
| 2/20/2013 | 60XCS99ANTI-ADRENERGIC, N.E.C. | 27DRUG GMPS | Southwest Import District Office (SWI-DO) |
| 8/23/2011 | 62CCA16DIAZOXIDE (ANTI-HYPERTENSIVE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/25/2008 | 62IIS82IDARUBICIN HYDROCHLORIDE (ANTI-NEOPLASTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/9/2007 | 56KAY90VIDARABINE | New Orleans District Office (NOL-DO) | |
| 1/22/2003 | 62GCS37FLUNIXIN MEGLUMINE (ANTI-INFLAMMATORY) | 72NEW VET DR | New York District Office (NYK-DO) |
| 1/22/2003 | 66SCS08ISOXSUPRINE HCL (VASODILATOR) | 72NEW VET DR | New York District Office (NYK-DO) |
| 12/31/2002 | 56DCS70STREPTOMYCIN (AMINOGLYCOSIDES) | 72NEW VET DR | New York District Office (NYK-DO) |
| 12/27/2002 | 60KCS03BOLDENONE UNDECYLENATE (ANABOLIC) | Southwest Import District Office (SWI-DO) | |
| 7/29/2002 | 66SRS08ISOXSUPRINE HCL (VASODILATOR) | 72NEW VET DR | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Transo-Pharm Handels GMBH's FDA import refusal history?
Transo-Pharm Handels GMBH (FEI: 3003773765) has 10 FDA import refusal record(s) in our database, spanning from 7/29/2002 to 1/10/2014.
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. Transo-Pharm Handels GMBH's FEI number is 3003773765.
What types of violations has Transo-Pharm Handels GMBH received?
Transo-Pharm Handels GMBH 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 Transo-Pharm Handels GMBH come from?
All FDA import refusal data for Transo-Pharm Handels 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.