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JINING SIX SECRETS TRADING CO.,LTD

⚠️ Moderate Risk

FEI: 3018390230 • Jining, Shandong • CHINA

FEI

FEI Number

3018390230

📍

Location

Jining, Shandong

🇨🇳

Country

CHINA
🏢

Address

Economic, Shizhong, Jining, Shandong, China

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
5/17/2021
Latest Refusal
5/17/2021
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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).

23801×

NO PMA/PDP

The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).

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
5/17/2021
79KGMSILICONE, LIQUID, INJECTABLE
118NOT LISTED
2380NO PMA/PDP
3280FRNMFGREG
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is JINING SIX SECRETS TRADING CO.,LTD's FDA import refusal history?

JINING SIX SECRETS TRADING CO.,LTD (FEI: 3018390230) has 1 FDA import refusal record(s) in our database, spanning from 5/17/2021 to 5/17/2021.

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. JINING SIX SECRETS TRADING CO.,LTD's FEI number is 3018390230.

What types of violations has JINING SIX SECRETS TRADING CO.,LTD received?

JINING SIX SECRETS TRADING 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 JINING SIX SECRETS TRADING CO.,LTD come from?

All FDA import refusal data for JINING SIX SECRETS TRADING 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.