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Foreign Trading Co., The

⚠️ Moderate Risk

FEI: 3003310169 • Guangzhou • CHINA

FEI

FEI Number

3003310169

📍

Location

Guangzhou

🇨🇳

Country

CHINA
🏢

Address

121-127 Liu Yong Roadyeuhhsiu Guangzhou, , Guangzhou, , China

Moderate Risk

FDA Import Risk Assessment

38.6
LowModerateHighCritical

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

Statistics

4
Total Refusals
5
Unique Violations
4/12/2002
Latest Refusal
4/12/2002
Earliest Refusal

Score Breakdown

Violation Severity
67.1×40%
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

1152×

DR QUALITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.

752×

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).

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).

271×

DRUG GMPS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

Refusal History

DateProductViolationsDivision
4/12/2002
63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC)
333LACKS FIRM
75UNAPPROVED
Los Angeles District Office (LOS-DO)
4/12/2002
63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC)
115DR QUALITY
118NOT LISTED
Los Angeles District Office (LOS-DO)
4/12/2002
63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC)
115DR QUALITY
Los Angeles District Office (LOS-DO)
4/12/2002
63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC)
27DRUG GMPS
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Foreign Trading Co., The's FDA import refusal history?

Foreign Trading Co., The (FEI: 3003310169) has 4 FDA import refusal record(s) in our database, spanning from 4/12/2002 to 4/12/2002.

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. Foreign Trading Co., The's FEI number is 3003310169.

What types of violations has Foreign Trading Co., The received?

Foreign Trading Co., The has been cited for 5 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 Foreign Trading Co., The come from?

All FDA import refusal data for Foreign Trading Co., The 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.