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NANJING ZELANG MEDICAL TECHNOLOGY CO.,LTD

⚠️ Moderate Risk

FEI: 3012302201 • Nanjing, Jiangsu • CHINA

FEI

FEI Number

3012302201

📍

Location

Nanjing, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

6th Floor, 05 Ganjiabian Dong; Qixia District, Nanjing, Jiangsu, China

Moderate Risk

FDA Import Risk Assessment

45.5
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
4/3/2025
Latest Refusal
12/21/2018
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
Refusal Volume
17.7×30%
Recency
69.3×20%
Frequency
3.2×10%
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

4731×

LABELING

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

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
4/3/2025
54YCR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
Division of West Coast Imports (DWCI)
12/21/2018
02GFT99FLOURS AND MEALS N.E.C.
473LABELING
Division of Southeast Imports (DSEI)

Frequently Asked Questions

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

NANJING ZELANG MEDICAL TECHNOLOGY CO.,LTD (FEI: 3012302201) has 2 FDA import refusal record(s) in our database, spanning from 12/21/2018 to 4/3/2025.

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 ZELANG MEDICAL TECHNOLOGY CO.,LTD's FEI number is 3012302201.

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

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

All FDA import refusal data for NANJING ZELANG 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.