Schering Deutschland Gmbh
⚠️ Moderate Risk
FEI: 3004442378 • Berlin, Berlin • GERMANY
FEI Number
3004442378
Location
Berlin, Berlin
Country
GERMANYAddress
Max-Dohrn-Str. 10, , Berlin, Berlin, 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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/11/2012 | 64GDB19ETHINYL ESTRADIOL (ESTROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/4/2009 | 64GCB07ESTRADIOL (ESTROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/17/2008 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/10/2007 | 64GCA13ESTRADIOL VALERATE (ESTROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/5/2007 | 64GDY13ESTRADIOL VALERATE (ESTROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/24/2006 | 64GDB29LEVONORGESTREL (ESTROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/25/2006 | 64GIA29LEVONORGESTREL (ESTROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/25/2006 | 64GIA29LEVONORGESTREL (ESTROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/13/2005 | 61WCP45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 11/13/2005 | 61BCP02CYPROTERONE ACETATE (ANTI-ANDROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/23/2004 | 65JCA31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/12/2004 | 65JBY31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Schering Deutschland Gmbh's FDA import refusal history?
Schering Deutschland Gmbh (FEI: 3004442378) has 12 FDA import refusal record(s) in our database, spanning from 4/12/2004 to 6/11/2012.
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. Schering Deutschland Gmbh's FEI number is 3004442378.
What types of violations has Schering Deutschland Gmbh received?
Schering 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 Schering Deutschland Gmbh come from?
All FDA import refusal data for Schering 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.