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Jiangsu Tianhe Medicinal Institute Co., Ltd.

✅ Low Risk

FEI: 3004541272 • Jiangsu • CHINA

FEI

FEI Number

3004541272

📍

Location

Jiangsu

🇨🇳

Country

CHINA
🏢

Address

66 North Kunlun Rd., Liyang,, , Jiangsu, , China

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
7/20/2012
Latest Refusal
7/20/2012
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

2601×

FALSE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

Refusal History

DateProductViolationsDivision
7/20/2012
54ABR02VITAMIN B1 (THIAMINE)
260FALSE
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Jiangsu Tianhe Medicinal Institute Co., Ltd.'s FDA import refusal history?

Jiangsu Tianhe Medicinal Institute Co., Ltd. (FEI: 3004541272) has 1 FDA import refusal record(s) in our database, spanning from 7/20/2012 to 7/20/2012.

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. Jiangsu Tianhe Medicinal Institute Co., Ltd.'s FEI number is 3004541272.

What types of violations has Jiangsu Tianhe Medicinal Institute Co., Ltd. received?

Jiangsu Tianhe Medicinal Institute 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 Jiangsu Tianhe Medicinal Institute Co., Ltd. come from?

All FDA import refusal data for Jiangsu Tianhe Medicinal Institute 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.