Lomapharm Rudolf Lohmann GmbH KG
⚠️ Moderate Risk
FEI: 1000634798 • Emmerthal, Lower Saxony • GERMANY
FEI Number
1000634798
Location
Emmerthal, Lower Saxony
Country
GERMANYAddress
Langes Feld 5, , Emmerthal, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/24/2007 | 56ECO80TETRACYCLINE (TETRACYCLINES) | New Orleans District Office (NOL-DO) | |
| 4/24/2007 | 56ECO80TETRACYCLINE (TETRACYCLINES) | New Orleans District Office (NOL-DO) | |
| 4/24/2007 | 65DCA04ERGONOVINE MALEATE (OXYTOCIC) | New Orleans District Office (NOL-DO) | |
| 4/24/2007 | 61KCA46SCOPOLAMINE HYDROBROMIDE (ANTI-CHOLINERGIC) | New Orleans District Office (NOL-DO) | |
| 12/28/2005 | 61HCA27PYRAZINAMIDE (ANTI-BACTERIAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Lomapharm Rudolf Lohmann GmbH KG's FDA import refusal history?
Lomapharm Rudolf Lohmann GmbH KG (FEI: 1000634798) has 5 FDA import refusal record(s) in our database, spanning from 12/28/2005 to 4/24/2007.
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. Lomapharm Rudolf Lohmann GmbH KG's FEI number is 1000634798.
What types of violations has Lomapharm Rudolf Lohmann GmbH KG received?
Lomapharm Rudolf Lohmann GmbH KG 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 Lomapharm Rudolf Lohmann GmbH KG come from?
All FDA import refusal data for Lomapharm Rudolf Lohmann GmbH KG 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.