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CHONGQING QIMEISI MEDICAL EQUIPMENT

✅ Low Risk

FEI: 3017376528 • Chongqing • CHINA

FEI

FEI Number

3017376528

📍

Location

Chongqing

🇨🇳

Country

CHINA
🏢

Address

4-2 B4 Bldg Dongben No18 Yuma Rd, , Chongqing, , China

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
10/21/2020
Latest Refusal
10/21/2020
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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).

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
10/21/2020
78FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE
118NOT LISTED
3280FRNMFGREG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is CHONGQING QIMEISI MEDICAL EQUIPMENT's FDA import refusal history?

CHONGQING QIMEISI MEDICAL EQUIPMENT (FEI: 3017376528) has 1 FDA import refusal record(s) in our database, spanning from 10/21/2020 to 10/21/2020.

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 QIMEISI MEDICAL EQUIPMENT's FEI number is 3017376528.

What types of violations has CHONGQING QIMEISI MEDICAL EQUIPMENT received?

CHONGQING QIMEISI MEDICAL EQUIPMENT 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 QIMEISI MEDICAL EQUIPMENT come from?

All FDA import refusal data for CHONGQING QIMEISI MEDICAL EQUIPMENT 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.