Fielmann Group AG
⚠️ Moderate Risk
FEI: 3000308604 • Hamburg, Hamburg • GERMANY
FEI Number
3000308604
Location
Hamburg, Hamburg
Country
GERMANYAddress
Weidestr. 118a, , 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).
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/18/2012 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 86HQZFRAME, SPECTACLE | New Orleans District Office (NOL-DO) | |
| 11/5/2010 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Fielmann Group AG's FDA import refusal history?
Fielmann Group AG (FEI: 3000308604) has 3 FDA import refusal record(s) in our database, spanning from 11/5/2010 to 6/18/2012.
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. Fielmann Group AG's FEI number is 3000308604.
What types of violations has Fielmann Group AG received?
Fielmann Group AG 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 Fielmann Group AG come from?
All FDA import refusal data for Fielmann Group AG 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.