Thymoorgan Pharmazie Gmbh
⚠️ Moderate Risk
FEI: 3002320821 • Goslar, Lower Saxony • GERMANY
FEI Number
3002320821
Location
Goslar, Lower Saxony
Country
GERMANYAddress
Schiffgraben 23, , Goslar, Lower Saxony, 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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/31/2022 | 62IIY67VINCRISTINE SULFATE (ANTI-NEOPLASTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/31/2022 | 56HIK24DOXORUBICIN HYDROCHLORIDE (ANTITUMOR) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/31/2022 | 62IIY67VINCRISTINE SULFATE (ANTI-NEOPLASTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/31/2022 | 56HIK24DOXORUBICIN HYDROCHLORIDE (ANTITUMOR) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 2/8/2012 | 62IDP60THIOTEPA (ANTI-NEOPLASTIC) | Baltimore District Office (BLT-DO) | |
| 11/29/2005 | 66VBK99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 2/10/2002 | 61ADA06CHLOROQUINE PHOSPHATE (ANTI-AMEBIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Thymoorgan Pharmazie Gmbh's FDA import refusal history?
Thymoorgan Pharmazie Gmbh (FEI: 3002320821) has 7 FDA import refusal record(s) in our database, spanning from 2/10/2002 to 10/31/2022.
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. Thymoorgan Pharmazie Gmbh's FEI number is 3002320821.
What types of violations has Thymoorgan Pharmazie Gmbh received?
Thymoorgan Pharmazie 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 Thymoorgan Pharmazie Gmbh come from?
All FDA import refusal data for Thymoorgan Pharmazie 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.