EFL GLOBAL FREEPORT (PVT) LTD
⚠️ Moderate Risk
FEI: 3015792609 • Katunayake, Gampaha • SRI LANKA
FEI Number
3015792609
Location
Katunayake, Gampaha
Country
SRI LANKAAddress
Phase 1, Lot No 117; Spur Road 3, Epz, Katunayake, Gampaha, Sri Lanka
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
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.
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/19/2020 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 3280FRNMFGREG | Division of Northern Border Imports (DNBI) |
| 2/10/2020 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of Southeast Imports (DSEI) | |
| 2/10/2020 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is EFL GLOBAL FREEPORT (PVT) LTD's FDA import refusal history?
EFL GLOBAL FREEPORT (PVT) LTD (FEI: 3015792609) has 3 FDA import refusal record(s) in our database, spanning from 2/10/2020 to 2/19/2020.
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. EFL GLOBAL FREEPORT (PVT) LTD's FEI number is 3015792609.
What types of violations has EFL GLOBAL FREEPORT (PVT) LTD received?
EFL GLOBAL FREEPORT (PVT) LTD has been cited for 3 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 EFL GLOBAL FREEPORT (PVT) LTD come from?
All FDA import refusal data for EFL GLOBAL FREEPORT (PVT) LTD 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.