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Changzhou Wujin Feida Chemical Co. Ltd.

⚠️ Moderate Risk

FEI: 3004986971 • Changzhou, Jiangsu • CHINA

FEI

FEI Number

3004986971

📍

Location

Changzhou, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

Sanhuangmiao Village, Zhenglu Shequ Juwei Hui; Wujin, Changzhou, Jiangsu, China

Moderate Risk

FDA Import Risk Assessment

43.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
7/2/2015
Latest Refusal
1/29/2015
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

752×

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
7/2/2015
60QAR56BENZOCAINE (ANESTHETIC)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
1/29/2015
60QAR56BENZOCAINE (ANESTHETIC)
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Changzhou Wujin Feida Chemical Co. Ltd.'s FDA import refusal history?

Changzhou Wujin Feida Chemical Co. Ltd. (FEI: 3004986971) has 2 FDA import refusal record(s) in our database, spanning from 1/29/2015 to 7/2/2015.

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. Changzhou Wujin Feida Chemical Co. Ltd.'s FEI number is 3004986971.

What types of violations has Changzhou Wujin Feida Chemical Co. Ltd. received?

Changzhou Wujin Feida Chemical 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 Changzhou Wujin Feida Chemical Co. Ltd. come from?

All FDA import refusal data for Changzhou Wujin Feida Chemical 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.