ImportRefusal LogoImportRefusal

Jintan Tianhua Chemical New Technology Institute

⚠️ Moderate Risk

FEI: 3006718741 • Jiangsu • CHINA

FEI

FEI Number

3006718741

📍

Location

Jiangsu

🇨🇳

Country

CHINA
🏢

Address

11 Magan Shoufeikou Jintan, , Jiangsu, , China

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/14/2008
Latest Refusal
10/14/2008
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

751×

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
10/14/2008
60QAS70TETRACAINE (ANESTHETIC)
75UNAPPROVED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Jintan Tianhua Chemical New Technology Institute's FDA import refusal history?

Jintan Tianhua Chemical New Technology Institute (FEI: 3006718741) has 1 FDA import refusal record(s) in our database, spanning from 10/14/2008 to 10/14/2008.

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. Jintan Tianhua Chemical New Technology Institute's FEI number is 3006718741.

What types of violations has Jintan Tianhua Chemical New Technology Institute received?

Jintan Tianhua Chemical New Technology Institute 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 Jintan Tianhua Chemical New Technology Institute come from?

All FDA import refusal data for Jintan Tianhua Chemical New Technology Institute 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.