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Dey'S Medical Stores Pvt. Ltd.

⚠️ Moderate Risk

FEI: 3003779515 • Kolkata, West Bengal • INDIA

FEI

FEI Number

3003779515

📍

Location

Kolkata, West Bengal

🇮🇳

Country

INDIA
🏢

Address

6 / 2 B Nelly Sengupta Sarani, , Kolkata, West Bengal, India

Moderate Risk

FDA Import Risk Assessment

25.2
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

4
Total Refusals
3
Unique Violations
8/5/2014
Latest Refusal
11/10/2011
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
14.6×10%
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

4733×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

4711×

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.

4751×

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.

Refusal History

DateProductViolationsDivision
8/5/2014
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
473LABELING
Southwest Import District Office (SWI-DO)
8/5/2014
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
473LABELING
Southwest Import District Office (SWI-DO)
11/13/2013
53ED07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
Seattle District Office (SEA-DO)
11/10/2011
53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.
473LABELING
475COSMETLBLG
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: 3003779515) has 4 FDA import refusal record(s) in our database, spanning from 11/10/2011 to 8/5/2014.

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. Dey'S Medical Stores Pvt. Ltd.'s FEI number is 3003779515.

What types of violations has Dey'S Medical Stores Pvt. Ltd. received?

Dey'S Medical Stores 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 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.