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Jiangsu Yongda Pharmaceutical Co., Ltd.

⚠️ High Risk

FEI: 3004908893 • Changzhou, Jiangsu • CHINA

FEI

FEI Number

3004908893

📍

Location

Changzhou, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

5 N. Gangqu Road, Chunjiang Township, Changzhou, Jiangsu, China

High Risk

FDA Import Risk Assessment

50.7
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

2
Total Refusals
1
Unique Violations
3/29/2024
Latest Refusal
7/14/2020
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
17.7×30%
Recency
64.3×20%
Frequency
5.4×10%
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

38452×

DRG REF EI

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article of drug appears to be adulterated under Section 501(j) because it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.

Refusal History

DateProductViolationsDivision
3/29/2024
61FOY61GATIFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)
3845DRG REF EI
Division of Southeast Imports (DSEI)
7/14/2020
61FOY61GATIFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)
3845DRG REF EI
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Jiangsu Yongda Pharmaceutical Co., Ltd.'s FDA import refusal history?

Jiangsu Yongda Pharmaceutical Co., Ltd. (FEI: 3004908893) has 2 FDA import refusal record(s) in our database, spanning from 7/14/2020 to 3/29/2024.

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. Jiangsu Yongda Pharmaceutical Co., Ltd.'s FEI number is 3004908893.

What types of violations has Jiangsu Yongda Pharmaceutical Co., Ltd. received?

Jiangsu Yongda 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 Jiangsu Yongda Pharmaceutical Co., Ltd. come from?

All FDA import refusal data for Jiangsu Yongda 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.