Herb-Xtra

⚠️ Moderate Risk

FEI: 3004634371 • Ste-Julie, QUEBEC • CANADA

FEI

FEI Number

3004634371

📍

Location

Ste-Julie, QUEBEC

🇨🇦

Country

CANADA

🏢

Address

2121-4 Leonard De Vinci, , Ste-Julie, QUEBEC, Canada

Moderate Risk

FDA Import Risk Assessment

40.2

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

7/28/2005

Latest Refusal

11/22/2004

Earliest Refusal

Score Breakdown

Violation Severity

40.0×40%

Refusal Volume

47.4×30%

Recency

0.0×20%

Frequency

100.0×10%

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

Violation Summary

230018×

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.

48217×

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

Date	Product	Violations	Division
7/28/2005	54YCC99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	2300DIETARYLBL	New York District Office (NYK-DO)
12/14/2004	54YCC99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	2300DIETARYLBL 482NUTRIT LBL	New York District Office (NYK-DO)
12/14/2004	54YCC99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	2300DIETARYLBL 482NUTRIT LBL	New York District Office (NYK-DO)
12/14/2004	54YCC99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	2300DIETARYLBL 482NUTRIT LBL	New York District Office (NYK-DO)
12/14/2004	54FCC64ST. JOHN'S WORT (HERBAL & BOTANICALS, NOT TEAS)	2300DIETARYLBL 482NUTRIT LBL	New York District Office (NYK-DO)
11/22/2004	54YCC99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	2300DIETARYLBL 482NUTRIT LBL	New York District Office (NYK-DO)
11/22/2004	54YCC99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	2300DIETARYLBL 482NUTRIT LBL	New York District Office (NYK-DO)
11/22/2004	54YCC99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	2300DIETARYLBL 482NUTRIT LBL	New York District Office (NYK-DO)
11/22/2004	54YCC99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	2300DIETARYLBL 482NUTRIT LBL	New York District Office (NYK-DO)
11/22/2004	54YCC99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	2300DIETARYLBL 482NUTRIT LBL	New York District Office (NYK-DO)
11/22/2004	54FCC33ASTRAGALUS (MILK VETCH ROOT), (HERBAL & BOTANICALS, NOT TEAS)	2300DIETARYLBL 482NUTRIT LBL	New York District Office (NYK-DO)
11/22/2004	54YCC99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	2300DIETARYLBL 482NUTRIT LBL	New York District Office (NYK-DO)
11/22/2004	54YCC99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	2300DIETARYLBL 482NUTRIT LBL	New York District Office (NYK-DO)
11/22/2004	54YCC99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	2300DIETARYLBL 482NUTRIT LBL	New York District Office (NYK-DO)
11/22/2004	54YCC99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	2300DIETARYLBL 482NUTRIT LBL	New York District Office (NYK-DO)
11/22/2004	54YCC99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	2300DIETARYLBL 482NUTRIT LBL	New York District Office (NYK-DO)
11/22/2004	54YCC99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	2300DIETARYLBL 482NUTRIT LBL	New York District Office (NYK-DO)
11/22/2004	54YCC99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	2300DIETARYLBL 482NUTRIT LBL	New York District Office (NYK-DO)

Frequently Asked Questions

What is Herb-Xtra's FDA import refusal history?

Herb-Xtra (FEI: 3004634371) has 18 FDA import refusal record(s) in our database, spanning from 11/22/2004 to 7/28/2005.

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. Herb-Xtra's FEI number is 3004634371.

What types of violations has Herb-Xtra received?

Herb-Xtra has been cited for 2 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 Herb-Xtra come from?

All FDA import refusal data for Herb-Xtra 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.