DR FRITZ BODEGmbh
⚠️ Moderate Risk
FEI: 3005147501 • Rheinfelden • GERMANY
FEI Number
3005147501
Location
Rheinfelden
Country
GERMANYAddress
No Address, , Rheinfelden, , 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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/7/2007 | 64LDJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | New York District Office (NYK-DO) | |
| 7/22/2005 | 64LCJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 473LABELING | New Orleans District Office (NOL-DO) |
| 7/22/2005 | 64LCJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is DR FRITZ BODEGmbh's FDA import refusal history?
DR FRITZ BODEGmbh (FEI: 3005147501) has 3 FDA import refusal record(s) in our database, spanning from 7/22/2005 to 8/7/2007.
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. DR FRITZ BODEGmbh's FEI number is 3005147501.
What types of violations has DR FRITZ BODEGmbh received?
DR FRITZ BODEGmbh 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 DR FRITZ BODEGmbh come from?
All FDA import refusal data for DR FRITZ BODEGmbh 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.