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HOOTONE REMEDIES

⚠️ Moderate Risk

FEI: 3006628665 • Thane, Maharashtra • INDIA

FEI

FEI Number

3006628665

📍

Location

Thane, Maharashtra

🇮🇳

Country

INDIA
🏢

Address

D/58 Mek Industrial Estate, , Thane, Maharashtra, India

Moderate Risk

FDA Import Risk Assessment

35.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
10/27/2011
Latest Refusal
10/27/2011
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

4884×

HEALTH C

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 bears an unauthorized nutrient content/health claim.

Refusal History

DateProductViolationsDivision
10/27/2011
54ECR99HERBALS & BOTANICAL TEAS, N.E.C.
488HEALTH C
New Orleans District Office (NOL-DO)
10/27/2011
54FEJ99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
488HEALTH C
New Orleans District Office (NOL-DO)
10/27/2011
54ECL99HERBALS & BOTANICAL TEAS, N.E.C.
488HEALTH C
New Orleans District Office (NOL-DO)
10/27/2011
54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
488HEALTH C
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is HOOTONE REMEDIES's FDA import refusal history?

HOOTONE REMEDIES (FEI: 3006628665) has 4 FDA import refusal record(s) in our database, spanning from 10/27/2011 to 10/27/2011.

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. HOOTONE REMEDIES's FEI number is 3006628665.

What types of violations has HOOTONE REMEDIES received?

HOOTONE REMEDIES 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 HOOTONE REMEDIES come from?

All FDA import refusal data for HOOTONE REMEDIES 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.