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NANJING HIMED MEDICAL TECHNOLOGY CO., LTD

⚠️ Moderate Risk

FEI: 3011496555 • Nanjing, Jiangsu • CHINA

FEI

FEI Number

3011496555

📍

Location

Nanjing, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

NO. 8 Xiushan Road, Gubo Development Zone, Nanjing, 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
1/4/2017
Latest Refusal
1/4/2017
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

781×

STERILITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
1/4/2017
79KGXTAPE AND BANDAGE, ADHESIVE
78STERILITY
New York District Office (NYK-DO)

Frequently Asked Questions

What is NANJING HIMED MEDICAL TECHNOLOGY CO., LTD's FDA import refusal history?

NANJING HIMED MEDICAL TECHNOLOGY CO., LTD (FEI: 3011496555) has 1 FDA import refusal record(s) in our database, spanning from 1/4/2017 to 1/4/2017.

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. NANJING HIMED MEDICAL TECHNOLOGY CO., LTD's FEI number is 3011496555.

What types of violations has NANJING HIMED MEDICAL TECHNOLOGY CO., LTD received?

NANJING HIMED MEDICAL TECHNOLOGY 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 NANJING HIMED MEDICAL TECHNOLOGY CO., LTD come from?

All FDA import refusal data for NANJING HIMED MEDICAL TECHNOLOGY 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.