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Yantai Dongcheng Biochemicals Co., Ltd.

⚠️ Moderate Risk

FEI: 3004248487 • Yantai, Shandong • CHINA

FEI

FEI Number

3004248487

📍

Location

Yantai, Shandong

🇨🇳

Country

CHINA
🏢

Address

No. 7 Changbaishan Road, Development Zone, Yantai, Shandong, China

Moderate Risk

FDA Import Risk Assessment

40.1
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
3/11/2010
Latest Refusal
8/28/2007
Earliest Refusal

Score Breakdown

Violation Severity
85.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
7.9×10%
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

1151×

DR QUALITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.

2491×

FILTHY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.

Refusal History

DateProductViolationsDivision
3/11/2010
61LCS08HEPARIN SODIUM (ANTI-COAGULANT)
115DR QUALITY
Southwest Import District Office (SWI-DO)
8/28/2007
54GBR04SHARK (ANIMAL BY-PRODUCTS AND EXTRACTS)
249FILTHY
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Yantai Dongcheng Biochemicals Co., Ltd.'s FDA import refusal history?

Yantai Dongcheng Biochemicals Co., Ltd. (FEI: 3004248487) has 2 FDA import refusal record(s) in our database, spanning from 8/28/2007 to 3/11/2010.

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. Yantai Dongcheng Biochemicals Co., Ltd.'s FEI number is 3004248487.

What types of violations has Yantai Dongcheng Biochemicals Co., Ltd. received?

Yantai Dongcheng Biochemicals 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 Yantai Dongcheng Biochemicals Co., Ltd. come from?

All FDA import refusal data for Yantai Dongcheng Biochemicals 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.