Kohinoor Chemical Co.(Bd)Ltd
⚠️ Moderate Risk
FEI: 3007384568 • Dhaka • BANGLADESH
FEI Number
3007384568
Location
Dhaka
Country
BANGLADESHAddress
36 Shahid Tejuddin Ahmed Soronitejgaon, , Dhaka, , Bangladesh
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
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).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/6/2023 | 53ED07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 2/6/2023 | 53ED07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 6/15/2016 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Kohinoor Chemical Co.(Bd)Ltd's FDA import refusal history?
Kohinoor Chemical Co.(Bd)Ltd (FEI: 3007384568) has 3 FDA import refusal record(s) in our database, spanning from 6/15/2016 to 2/6/2023.
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. Kohinoor Chemical Co.(Bd)Ltd's FEI number is 3007384568.
What types of violations has Kohinoor Chemical Co.(Bd)Ltd received?
Kohinoor Chemical Co.(Bd)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 Kohinoor Chemical Co.(Bd)Ltd come from?
All FDA import refusal data for Kohinoor Chemical Co.(Bd)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.