Harro Hofliger
✅ Low Risk
FEI: 3004855793 • Allmersbach Im Tal • GERMANY
FEI Number
3004855793
Location
Allmersbach Im Tal
Country
GERMANYAddress
Postfach 36, , Allmersbach Im Tal, , Germany
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/11/2017 | 78FONBAG, DRAINAGE, WITH ADHESIVE, OSTOMY | 3280FRNMFGREG | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Harro Hofliger's FDA import refusal history?
Harro Hofliger (FEI: 3004855793) has 1 FDA import refusal record(s) in our database, spanning from 1/11/2017 to 1/11/2017.
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. Harro Hofliger's FEI number is 3004855793.
What types of violations has Harro Hofliger received?
Harro Hofliger 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 Harro Hofliger come from?
All FDA import refusal data for Harro Hofliger 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.