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Health Herb Products Co Ltd

⚠️ Moderate Risk

FEI: 3003235639 • Samutprakarn • THAILAND

FEI

FEI Number

3003235639

📍

Location

Samutprakarn

🇹🇭

Country

THAILAND
🏢

Address

202/5 Moo 2 Soi Pookmitr, , Samutprakarn, , Thailand

Moderate Risk

FDA Import Risk Assessment

39.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
6/15/2004
Latest Refusal
3/31/2004
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

2511×

POISONOUS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:

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
6/15/2004
54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
251POISONOUS
San Francisco District Office (SAN-DO)
3/31/2004
60NBH99ANDROGEN, N.E.C.
118NOT LISTED
75UNAPPROVED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Health Herb Products Co Ltd's FDA import refusal history?

Health Herb Products Co Ltd (FEI: 3003235639) has 2 FDA import refusal record(s) in our database, spanning from 3/31/2004 to 6/15/2004.

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. Health Herb Products Co Ltd's FEI number is 3003235639.

What types of violations has Health Herb Products Co Ltd received?

Health Herb Products Co 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 Health Herb Products Co Ltd come from?

All FDA import refusal data for Health Herb Products Co 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.