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SHENZHEN JYMED TECHNOLOGY CO., LTD.

⚠️ High Risk

FEI: 3017011537 • Shenzhen • CHINA

FEI

FEI Number

3017011537

📍

Location

Shenzhen

🇨🇳

Country

CHINA
🏢

Address

Rm. 806-810 F/#-8, 1 Biomedicine Inn, Shenzhen, , China

High Risk

FDA Import Risk Assessment

51.8
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/27/2023
Latest Refusal
11/27/2023
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
57.0×20%
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
11/27/2023
61PCZ74TIRZEPATIDE (ANTI-DIABETIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SHENZHEN JYMED TECHNOLOGY CO., LTD.'s FDA import refusal history?

SHENZHEN JYMED TECHNOLOGY CO., LTD. (FEI: 3017011537) has 1 FDA import refusal record(s) in our database, spanning from 11/27/2023 to 11/27/2023.

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. SHENZHEN JYMED TECHNOLOGY CO., LTD.'s FEI number is 3017011537.

What types of violations has SHENZHEN JYMED TECHNOLOGY CO., LTD. received?

SHENZHEN JYMED 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 SHENZHEN JYMED TECHNOLOGY CO., LTD. come from?

All FDA import refusal data for SHENZHEN JYMED 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.