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Jiangxi Tianxin Pharmaceutical Co., Ltd.

⚠️ Moderate Risk

FEI: 3006661959 • Leping, Jiangxi • CHINA

FEI

FEI Number

3006661959

📍

Location

Leping, Jiangxi

🇨🇳

Country

CHINA
🏢

Address

Leanjiang Industrial Park, , Leping, Jiangxi, China

Moderate Risk

FDA Import Risk Assessment

40.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/23/2024
Latest Refusal
10/23/2024
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
61.7×20%
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
10/23/2024
54AFZ14VIT D
2280DIRSEXMPT
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Jiangxi Tianxin Pharmaceutical Co., Ltd.'s FDA import refusal history?

Jiangxi Tianxin Pharmaceutical Co., Ltd. (FEI: 3006661959) has 1 FDA import refusal record(s) in our database, spanning from 10/23/2024 to 10/23/2024.

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. Jiangxi Tianxin Pharmaceutical Co., Ltd.'s FEI number is 3006661959.

What types of violations has Jiangxi Tianxin Pharmaceutical Co., Ltd. received?

Jiangxi Tianxin 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 Jiangxi Tianxin Pharmaceutical Co., Ltd. come from?

All FDA import refusal data for Jiangxi Tianxin 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.