Marlies Schulze Halberg
⚠️ Moderate Risk
FEI: 3007392544 • Erlangen, Bavaria • GERMANY
FEI Number
3007392544
Location
Erlangen, Bavaria
Country
GERMANYAddress
Seebachweg 25, , Erlangen, Bavaria, 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
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/26/2009 | 61TCA99ANTI-EMETIC/NAUSEANT N.E.C. | New York District Office (NYK-DO) | |
| 3/26/2009 | 62TCA06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | New York District Office (NYK-DO) | |
| 3/26/2009 | 60SCA24RANITIDINE BISMUTH CITRATE (ANTACID) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Marlies Schulze Halberg's FDA import refusal history?
Marlies Schulze Halberg (FEI: 3007392544) has 3 FDA import refusal record(s) in our database, spanning from 3/26/2009 to 3/26/2009.
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. Marlies Schulze Halberg's FEI number is 3007392544.
What types of violations has Marlies Schulze Halberg received?
Marlies Schulze Halberg 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 Marlies Schulze Halberg come from?
All FDA import refusal data for Marlies Schulze Halberg 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.