ESKAYEF PHARMACEUTICALS LTD
⚠️ High Risk
FEI: 3015396246 • Dhaka • BANGLADESH
FEI Number
3015396246
Location
Dhaka
Country
BANGLADESHAddress
158 Kamal Atatur Avenue, , Dhaka, , Bangladesh
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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.
Refusal History
Frequently Asked Questions
What is ESKAYEF PHARMACEUTICALS LTD's FDA import refusal history?
ESKAYEF PHARMACEUTICALS LTD (FEI: 3015396246) has 2 FDA import refusal record(s) in our database, spanning from 8/6/2019 to 10/7/2025.
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. ESKAYEF PHARMACEUTICALS LTD's FEI number is 3015396246.
What types of violations has ESKAYEF PHARMACEUTICALS LTD received?
ESKAYEF PHARMACEUTICALS 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 ESKAYEF PHARMACEUTICALS LTD come from?
All FDA import refusal data for ESKAYEF PHARMACEUTICALS 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.