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Elder Pharmaceuticals Ltd

⚠️ Moderate Risk

FEI: 3007517015 • Dehradun • INDIA

FEI

FEI Number

3007517015

📍

Location

Dehradun

🇮🇳

Country

INDIA
🏢

Address

Plot C-11/1 Industrial Area, , Selaqui, Dehradun, , India

Moderate Risk

FDA Import Risk Assessment

27.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
9/21/2012
Latest Refusal
9/21/2012
Earliest Refusal

Score Breakdown

Violation Severity
56.7×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

111×

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

36811×

NCONTACTS

The product is a dietary supplement that is marketed in the United States and appears to not have a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event.

4821×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

Refusal History

DateProductViolationsDivision
9/21/2012
54BEA01CALCIUM (MINERAL)
11UNSAFE COL
3681NCONTACTS
482NUTRIT LBL
New York District Office (NYK-DO)

Frequently Asked Questions

What is Elder Pharmaceuticals Ltd's FDA import refusal history?

Elder Pharmaceuticals Ltd (FEI: 3007517015) has 1 FDA import refusal record(s) in our database, spanning from 9/21/2012 to 9/21/2012.

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. Elder Pharmaceuticals Ltd's FEI number is 3007517015.

What types of violations has Elder Pharmaceuticals Ltd received?

Elder 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 Elder Pharmaceuticals Ltd come from?

All FDA import refusal data for Elder 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.