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JIAXING TIANHE PHARMACEUTICAL CO., LTD.

⚠️ Moderate Risk

FEI: 3016413378 • Jiaxing, Zhejiang • CHINA

FEI

FEI Number

3016413378

📍

Location

Jiaxing, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

Bldg. 3, #, Zhongfa Foreign Trade Industrial Zone, Fengqiao Town, Nanhu District, Jiaxing, Zhejiang, China

Moderate Risk

FDA Import Risk Assessment

27.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/17/2022
Latest Refusal
6/17/2022
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
14.6×20%
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).

Refusal History

DateProductViolationsDivision
6/17/2022
78KNXCOLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is JIAXING TIANHE PHARMACEUTICAL CO., LTD.'s FDA import refusal history?

JIAXING TIANHE PHARMACEUTICAL CO., LTD. (FEI: 3016413378) has 1 FDA import refusal record(s) in our database, spanning from 6/17/2022 to 6/17/2022.

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. JIAXING TIANHE PHARMACEUTICAL CO., LTD.'s FEI number is 3016413378.

What types of violations has JIAXING TIANHE PHARMACEUTICAL CO., LTD. received?

JIAXING TIANHE PHARMACEUTICAL 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 JIAXING TIANHE PHARMACEUTICAL CO., LTD. come from?

All FDA import refusal data for JIAXING TIANHE 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.