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GFR PHARMA

⚠️ Moderate Risk

FEI: 3012243004 • Maple Ridge, British Columbia • CANADA

FEI

FEI Number

3012243004

📍

Location

Maple Ridge, British Columbia

🇨🇦

Country

CANADA
🏢

Address

11450 201a St, , Maple Ridge, British Columbia, Canada

Moderate Risk

FDA Import Risk Assessment

32.5
LowModerateHighCritical

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

Statistics

7
Total Refusals
6
Unique Violations
5/12/2014
Latest Refusal
5/13/2008
Earliest Refusal

Score Breakdown

Violation Severity
53.3×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
11.7×10%
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).

31402×

SBGINSENG

The article is subject to refusal of admission in that it appears to be Misbranded because it or its ingredients purport to be or are represented as Ginseng, but are not an herb or herbal ingredient derived from a plant classified within the genus Panax.

2181×

LIST INGRE

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(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

3201×

LACKS FIRM

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(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.

4711×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

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
5/12/2014
54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
320LACKS FIRM
482NUTRIT LBL
Seattle District Office (SEA-DO)
4/11/2014
54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
Seattle District Office (SEA-DO)
4/11/2014
54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
Seattle District Office (SEA-DO)
12/16/2010
54YCF99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
471CSTIC LBLG
75UNAPPROVED
Seattle District Office (SEA-DO)
6/3/2008
54FCA03ANGELICA (HERBAL & BOTANICALS, NOT TEAS)
218LIST INGRE
New York District Office (NYK-DO)
5/13/2008
54YCA04GINSENG UNCONVENTIONAL DIETARY SPECIALITY FOR HUMANS OR ANIMALS
3140SBGINSENG
New York District Office (NYK-DO)
5/13/2008
54YCA04GINSENG UNCONVENTIONAL DIETARY SPECIALITY FOR HUMANS OR ANIMALS
3140SBGINSENG
New York District Office (NYK-DO)

Frequently Asked Questions

What is GFR PHARMA's FDA import refusal history?

GFR PHARMA (FEI: 3012243004) has 7 FDA import refusal record(s) in our database, spanning from 5/13/2008 to 5/12/2014.

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. GFR PHARMA's FEI number is 3012243004.

What types of violations has GFR PHARMA received?

GFR PHARMA has been cited for 6 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 GFR PHARMA come from?

All FDA import refusal data for GFR PHARMA 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.