Bushnell Outdoor Products
⚠️ Moderate Risk
FEI: 3005729049 • Suresnes, Hauts de Seine • FRANCE
FEI Number
3005729049
Location
Suresnes, Hauts de Seine
Country
FRANCEAddress
4 Rue Diderot, , Suresnes, Hauts de Seine, France
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 |
|---|---|---|---|
| 3/1/2010 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Chicago District Office (CHI-DO) | |
| 3/1/2010 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Chicago District Office (CHI-DO) | |
| 3/1/2010 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Chicago District Office (CHI-DO) | |
| 3/1/2010 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Chicago District Office (CHI-DO) | |
| 3/1/2010 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Bushnell Outdoor Products's FDA import refusal history?
Bushnell Outdoor Products (FEI: 3005729049) has 5 FDA import refusal record(s) in our database, spanning from 3/1/2010 to 3/1/2010.
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. Bushnell Outdoor Products's FEI number is 3005729049.
What types of violations has Bushnell Outdoor Products received?
Bushnell Outdoor Products 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 Bushnell Outdoor Products come from?
All FDA import refusal data for Bushnell Outdoor Products 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.