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CHONGQING GUOGUI TRADE CO LTD

⚠️ Moderate Risk

FEI: 3013005549 • Chongqing • CHINA

FEI

FEI Number

3013005549

📍

Location

Chongqing

🇨🇳

Country

CHINA
🏢

Address

NO 16 Jinghong Chi Rd, , Chongqing, , China

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
2/8/2017
Latest Refusal
2/8/2017
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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).

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
2/8/2017
62ICY91PACLITAXEL (ANTI-NEOPLASTIC)
118NOT LISTED
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is CHONGQING GUOGUI TRADE CO LTD's FDA import refusal history?

CHONGQING GUOGUI TRADE CO LTD (FEI: 3013005549) has 1 FDA import refusal record(s) in our database, spanning from 2/8/2017 to 2/8/2017.

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. CHONGQING GUOGUI TRADE CO LTD's FEI number is 3013005549.

What types of violations has CHONGQING GUOGUI TRADE CO LTD received?

CHONGQING GUOGUI TRADE CO LTD 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 CHONGQING GUOGUI TRADE CO LTD come from?

All FDA import refusal data for CHONGQING GUOGUI TRADE 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.