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Gaia Herbs Inc

⚠️ Moderate Risk

FEI: 3000274661 • Brevard, NC • UNITED STATES

FEI

FEI Number

3000274661

📍

Location

Brevard, NC

🇺🇸
🏢

Address

101 Gaia Herbs Rd, , Brevard, NC, United States

Moderate Risk

FDA Import Risk Assessment

30.3
LowModerateHighCritical

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

Statistics

5
Total Refusals
3
Unique Violations
11/22/2004
Latest Refusal
11/19/2004
Earliest Refusal

Score Breakdown

Violation Severity
41.7×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

23004×

DIETARYLBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.

2601×

FALSE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

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
11/22/2004
54YFL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
2300DIETARYLBL
New York District Office (NYK-DO)
11/22/2004
54YFL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
2300DIETARYLBL
New York District Office (NYK-DO)
11/22/2004
54YFL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
2300DIETARYLBL
New York District Office (NYK-DO)
11/22/2004
54YFL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
2300DIETARYLBL
New York District Office (NYK-DO)
11/19/2004
54YFL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
260FALSE
482NUTRIT LBL
New York District Office (NYK-DO)

Frequently Asked Questions

What is Gaia Herbs Inc's FDA import refusal history?

Gaia Herbs Inc (FEI: 3000274661) has 5 FDA import refusal record(s) in our database, spanning from 11/19/2004 to 11/22/2004.

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. Gaia Herbs Inc's FEI number is 3000274661.

What types of violations has Gaia Herbs Inc received?

Gaia Herbs Inc 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 Gaia Herbs Inc come from?

All FDA import refusal data for Gaia Herbs Inc 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.