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Fadna Food And Nature Pvt Ltd

⚠️ Moderate Risk

FEI: 3008748450 • Maharagamamaharagama • SRI LANKA

FEI

FEI Number

3008748450

📍

Location

Maharagamamaharagama

🇱🇰

Country

SRI LANKA
🏢

Address

63/88, Dambahena Road, , Maharagamamaharagama, , Sri Lanka

Moderate Risk

FDA Import Risk Assessment

45.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
2/21/2012
Latest Refusal
2/21/2012
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

753×

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
2/21/2012
31KFH02TEA, GREEN
75UNAPPROVED
San Francisco District Office (SAN-DO)
2/21/2012
31KFH02TEA, GREEN
75UNAPPROVED
San Francisco District Office (SAN-DO)
2/21/2012
61PBY99ANTI-DIABETIC N.E.C.
75UNAPPROVED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Fadna Food And Nature Pvt Ltd's FDA import refusal history?

Fadna Food And Nature Pvt Ltd (FEI: 3008748450) has 3 FDA import refusal record(s) in our database, spanning from 2/21/2012 to 2/21/2012.

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. Fadna Food And Nature Pvt Ltd's FEI number is 3008748450.

What types of violations has Fadna Food And Nature Pvt Ltd received?

Fadna Food And Nature Pvt Ltd 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 Fadna Food And Nature Pvt Ltd come from?

All FDA import refusal data for Fadna Food And Nature 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.