Hans Hepp Gmbh & Co. Kg
⚠️ Moderate Risk
FEI: 3003364331 • Hamburg, Hamburg • GERMANY
FEI Number
3003364331
Location
Hamburg, Hamburg
Country
GERMANYAddress
Georgswerder Damm 16, , Hamburg, Hamburg, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/18/2008 | 79KGXTAPE AND BANDAGE, ADHESIVE | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 3/18/2008 | 79KGXTAPE AND BANDAGE, ADHESIVE | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 3/18/2008 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 3/18/2008 | 79GEMGAUZE, ABSORBABLE | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 3/18/2008 | 79KGXTAPE AND BANDAGE, ADHESIVE | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 3/18/2008 | 79KGXTAPE AND BANDAGE, ADHESIVE | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 3/18/2008 | 80NPDSURGEON'S GLOVES, POWDER FREE | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 3/18/2008 | 79GEMGAUZE, ABSORBABLE | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 3/18/2008 | 79KGXTAPE AND BANDAGE, ADHESIVE | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 3/18/2008 | 79KGXTAPE AND BANDAGE, ADHESIVE | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 3/18/2008 | 79GEMGAUZE, ABSORBABLE | 118NOT LISTED | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Hans Hepp Gmbh & Co. Kg's FDA import refusal history?
Hans Hepp Gmbh & Co. Kg (FEI: 3003364331) has 11 FDA import refusal record(s) in our database, spanning from 3/18/2008 to 3/18/2008.
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. Hans Hepp Gmbh & Co. Kg's FEI number is 3003364331.
What types of violations has Hans Hepp Gmbh & Co. Kg received?
Hans Hepp Gmbh & Co. Kg has been cited for 1 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 Hans Hepp Gmbh & Co. Kg come from?
All FDA import refusal data for Hans Hepp Gmbh & Co. 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.