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Shandong Jincheng Bio-pharmaceutical Co., Ltd

⚠️ Moderate Risk

FEI: 3010052966 • Zibo, Shandong • CHINA

FEI

FEI Number

3010052966

📍

Location

Zibo, Shandong

🇨🇳

Country

CHINA
🏢

Address

West Of Dongyi Road, Jiaowang Road, Zichuan Economic Development Zone, Zibo, 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
2
Unique Violations
1/5/2021
Latest Refusal
1/5/2021
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

38691×

708LBLFIRM

The article has been determined to to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

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
1/5/2021
60BDA20METHIONINE (ACIDIFIER)
3869708LBLFIRM
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Shandong Jincheng Bio-pharmaceutical Co., Ltd's FDA import refusal history?

Shandong Jincheng Bio-pharmaceutical Co., Ltd (FEI: 3010052966) has 1 FDA import refusal record(s) in our database, spanning from 1/5/2021 to 1/5/2021.

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. Shandong Jincheng Bio-pharmaceutical Co., Ltd's FEI number is 3010052966.

What types of violations has Shandong Jincheng Bio-pharmaceutical Co., Ltd received?

Shandong Jincheng Bio-pharmaceutical 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 Shandong Jincheng Bio-pharmaceutical Co., Ltd come from?

All FDA import refusal data for Shandong Jincheng Bio-pharmaceutical 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.