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G D Pharmaceuticals Private Limited

⚠️ Moderate Risk

FEI: 3008623539 • Kolkata, West Bengal • INDIA

FEI

FEI Number

3008623539

📍

Location

Kolkata, West Bengal

🇮🇳

Country

INDIA
🏢

Address

94 Asha Mahal, Nalini Ranjan Avenue, Kolkata, West Bengal, India

Moderate Risk

FDA Import Risk Assessment

38.5
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
12/1/2023
Latest Refusal
12/1/2023
Earliest Refusal

Score Breakdown

Violation Severity
56.7×40%
Refusal Volume
11.2×30%
Recency
57.2×20%
Frequency
10.0×10%
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

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.

751×

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).

Refusal History

DateProductViolationsDivision
12/1/2023
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
475COSMETLBLG
75UNAPPROVED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is G D Pharmaceuticals Private Limited's FDA import refusal history?

G D Pharmaceuticals Private Limited (FEI: 3008623539) has 1 FDA import refusal record(s) in our database, spanning from 12/1/2023 to 12/1/2023.

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. G D Pharmaceuticals Private Limited's FEI number is 3008623539.

What types of violations has G D Pharmaceuticals Private Limited received?

G D Pharmaceuticals Private Limited 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 G D Pharmaceuticals Private Limited come from?

All FDA import refusal data for G D Pharmaceuticals Private Limited 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.