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FOSHAN MD CO.,LTD

⚠️ Moderate Risk

FEI: 3026915571 • Weifang • CHINA

FEI

FEI Number

3026915571

📍

Location

Weifang

🇨🇳

Country

CHINA
🏢

Address

(Spb-A) (N3p) 1-4 Wangdian Bldg 15, , Weifang, , China

Moderate Risk

FDA Import Risk Assessment

36.5
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
6/7/2023
Latest Refusal
6/7/2023
Earliest Refusal

Score Breakdown

Violation Severity
56.7×40%
Refusal Volume
11.2×30%
Recency
47.5×20%
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.

471×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

Refusal History

DateProductViolationsDivision
6/7/2023
90EHBCOLLIMATOR, X-RAY
118NOT LISTED
3280FRNMFGREG
47NON STD
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is FOSHAN MD CO.,LTD's FDA import refusal history?

FOSHAN MD CO.,LTD (FEI: 3026915571) has 1 FDA import refusal record(s) in our database, spanning from 6/7/2023 to 6/7/2023.

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. FOSHAN MD CO.,LTD's FEI number is 3026915571.

What types of violations has FOSHAN MD CO.,LTD received?

FOSHAN MD CO.,LTD has been cited for 3 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 FOSHAN MD CO.,LTD come from?

All FDA import refusal data for FOSHAN MD 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.