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Amicogen (China) Biopharm Co., Ltd.

⚠️ Moderate Risk

FEI: 3013147895 • Jining, Shandong • CHINA

FEI

FEI Number

3013147895

📍

Location

Jining, Shandong

🇨🇳

Country

CHINA
🏢

Address

1688 Shixian Road, Ren Cheng, 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
1
Unique Violations
12/29/2020
Latest Refusal
12/29/2020
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

22801×

DIRSEXMPT

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.

Refusal History

DateProductViolationsDivision
12/29/2020
56YRS99ANTIBIOTIC N.E.C.
2280DIRSEXMPT
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Amicogen (China) Biopharm Co., Ltd.'s FDA import refusal history?

Amicogen (China) Biopharm Co., Ltd. (FEI: 3013147895) has 1 FDA import refusal record(s) in our database, spanning from 12/29/2020 to 12/29/2020.

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. Amicogen (China) Biopharm Co., Ltd.'s FEI number is 3013147895.

What types of violations has Amicogen (China) Biopharm Co., Ltd. received?

Amicogen (China) Biopharm Co., Ltd. has been cited for 1 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 Amicogen (China) Biopharm Co., Ltd. come from?

All FDA import refusal data for Amicogen (China) Biopharm 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.