Simtra Deutschland GmbH
⚠️ High Risk
FEI: 3002806419 • Halle (Westf.), North Rhine-Westphalia • GERMANY
FEI Number
3002806419
Location
Halle (Westf.), North Rhine-Westphalia
Country
GERMANYAddress
Kant Str. 2, , Halle (Westf.), 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 |
|---|---|---|---|
| 7/11/2024 | 64FIZ99ENZYME INHIBITOR N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 7/11/2024 | 62IIL92PENTOSTATIN (ANTI-NEOPLASTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/1/2023 | 64OIZ99MONOCLONAL ANTIBODIES, N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 4/14/2022 | 64MDY05MENOTROPINS (GONAD-STIMULATING PRINCIPLE) | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 4/14/2022 | 64MDY10UROFOLLITROPIN (GONAD-STIMULATING PRINCIPLE) | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 12/9/2004 | 64DCL99EMOLLIENT, LUBRICANT, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 10/14/2004 | 64UDL99INHIBITOR N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Simtra Deutschland GmbH's FDA import refusal history?
Simtra Deutschland GmbH (FEI: 3002806419) has 7 FDA import refusal record(s) in our database, spanning from 10/14/2004 to 7/11/2024.
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. Simtra Deutschland GmbH's FEI number is 3002806419.
What types of violations has Simtra Deutschland GmbH received?
Simtra Deutschland 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 Simtra Deutschland GmbH come from?
All FDA import refusal data for Simtra Deutschland 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.