Dey'S Medical Stores Pvt Ltd.,
⚠️ High Risk
FEI: 3004526363 • Kolkata, West Bengal • INDIA
FEI Number
3004526363
Location
Kolkata, West Bengal
Country
INDIAAddress
542, , Kolkata, West Bengal, India
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
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
COSMETFPLA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain an undeclared color additive which renders it misbranded within the meaning of Sections 1454(c)(3)(B) and 1456 of the Fair Packaging and Labeling Act.
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
COSM MISB2
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears that its labeling is false or misleading in any particular.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/11/2024 | 53EC01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | Division of Northeast Imports (DNEI) | |
| 9/3/2024 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 197COSM COLOR | Division of Northeast Imports (DNEI) |
| 9/3/2024 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 197COSM COLOR | Division of Northeast Imports (DNEI) |
| 8/20/2024 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | Division of Northeast Imports (DNEI) | |
| 8/20/2024 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | Division of Northeast Imports (DNEI) | |
| 8/20/2024 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | Division of Northeast Imports (DNEI) | |
| 5/22/2024 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | Division of Northeast Imports (DNEI) | |
| 5/22/2024 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | Division of Northeast Imports (DNEI) | |
| 5/22/2024 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | Division of Northeast Imports (DNEI) | |
| 1/24/2024 | 53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 197COSM COLOR | Division of Northern Border Imports (DNBI) |
| 5/23/2023 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | Division of Northeast Imports (DNEI) | |
| 5/1/2023 | 53ED07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | Division of Northeast Imports (DNEI) | |
| 5/1/2023 | 53ED07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | Division of Northeast Imports (DNEI) | |
| 10/13/2022 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 197COSM COLOR | Division of Northeast Imports (DNEI) |
| 1/30/2017 | 53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | Division of Northern Border Imports (DNBI) | |
| 8/12/2014 | 53ED07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | Chicago District Office (CHI-DO) | |
| 11/10/2011 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Dey'S Medical Stores Pvt Ltd.,'s FDA import refusal history?
Dey'S Medical Stores Pvt Ltd., (FEI: 3004526363) has 17 FDA import refusal record(s) in our database, spanning from 11/10/2011 to 10/11/2024.
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. Dey'S Medical Stores Pvt Ltd.,'s FEI number is 3004526363.
What types of violations has Dey'S Medical Stores Pvt Ltd., received?
Dey'S Medical Stores Pvt Ltd., has been cited for 7 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 Dey'S Medical Stores Pvt Ltd., come from?
All FDA import refusal data for Dey'S Medical Stores 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.