Harry Larry
✅ Low Risk
FEI: 3004199527 • Boulogne • FRANCE
FEI Number
3004199527
Location
Boulogne
Country
FRANCEAddress
48 Jean Baptiste Clement Ave, , Boulogne, , France
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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/8/2005 | 86HQZFRAME, SPECTACLE | 341REGISTERED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Harry Larry's FDA import refusal history?
Harry Larry (FEI: 3004199527) has 1 FDA import refusal record(s) in our database, spanning from 3/8/2005 to 3/8/2005.
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. Harry Larry's FEI number is 3004199527.
What types of violations has Harry Larry received?
Harry Larry 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 Harry Larry come from?
All FDA import refusal data for Harry Larry 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.