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Zydus Wellness

⚠️ Moderate Risk

FEI: 3009624912 • South Sikkim, South Sikkim • INDIA

FEI

FEI Number

3009624912

📍

Location

South Sikkim, South Sikkim

🇮🇳

Country

INDIA
🏢

Address

Near Mamring Power House, Mamring, South Sikkim, South Sikkim, India

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
3/28/2014
Latest Refusal
3/28/2014
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

1782×

COL ADDED

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

Refusal History

DateProductViolationsDivision
3/28/2014
64ABJ20TRICLOSAN (DISINFECTANT)
178COL ADDED
New England District Office (NWE-DO)
3/28/2014
64ABJ20TRICLOSAN (DISINFECTANT)
178COL ADDED
New England District Office (NWE-DO)

Frequently Asked Questions

What is Zydus Wellness's FDA import refusal history?

Zydus Wellness (FEI: 3009624912) has 2 FDA import refusal record(s) in our database, spanning from 3/28/2014 to 3/28/2014.

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. Zydus Wellness's FEI number is 3009624912.

What types of violations has Zydus Wellness received?

Zydus Wellness has been cited for 1 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 Zydus Wellness come from?

All FDA import refusal data for Zydus Wellness 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.