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Jiangsu Gaochun Ceramics Fty

⚠️ Moderate Risk

FEI: 1000110522 • Nanjing, Jiangsu • CHINA

FEI

FEI Number

1000110522

📍

Location

Nanjing, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

Gucheng Lao Street, Gaochunxian, Nanjing, Jiangsu, China

Moderate Risk

FDA Import Risk Assessment

30.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
4/15/2009
Latest Refusal
4/15/2009
Earliest Refusal

Score Breakdown

Violation Severity
47.5×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

4733×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

DateProductViolationsDivision
4/15/2009
66SBY99VASODILATOR N.E.C.
473LABELING
New York District Office (NYK-DO)
4/15/2009
66SBY99VASODILATOR N.E.C.
473LABELING
New York District Office (NYK-DO)
4/15/2009
62UBY99ANTI-TUSSIVE/COLD N.E.C.
473LABELING
New York District Office (NYK-DO)
4/15/2009
64BBY99DIURETIC N.E.C.
16DIRECTIONS
New York District Office (NYK-DO)

Frequently Asked Questions

What is Jiangsu Gaochun Ceramics Fty's FDA import refusal history?

Jiangsu Gaochun Ceramics Fty (FEI: 1000110522) has 4 FDA import refusal record(s) in our database, spanning from 4/15/2009 to 4/15/2009.

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 Gaochun Ceramics Fty's FEI number is 1000110522.

What types of violations has Jiangsu Gaochun Ceramics Fty received?

Jiangsu Gaochun Ceramics Fty has been cited for 2 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 Gaochun Ceramics Fty come from?

All FDA import refusal data for Jiangsu Gaochun Ceramics Fty 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.