Encore Inc
⚠️ Moderate Risk
FEI: 3009510572 • Louisville, KY • UNITED STATES
FEI Number
3009510572
Location
Louisville, KY
Country
UNITED STATESAddress
9100 Shelbyville Rd Ste 170, , Louisville, KY, United States
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
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/13/2014 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 237NO PMA | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Encore Inc's FDA import refusal history?
Encore Inc (FEI: 3009510572) has 1 FDA import refusal record(s) in our database, spanning from 1/13/2014 to 1/13/2014.
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. Encore Inc's FEI number is 3009510572.
What types of violations has Encore Inc received?
Encore Inc 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 Encore Inc come from?
All FDA import refusal data for Encore Inc 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.