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Core Technology Co. Ltd.

⚠️ Moderate Risk

FEI: 3008054239 • Beijing, Beijing • CHINA

FEI

FEI Number

3008054239

📍

Location

Beijing, Beijing

🇨🇳

Country

CHINA
🏢

Address

Building C Room 100, Life Park Rd; Changping District, Beijing, Beijing, China

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/2/2020
Latest Refusal
11/2/2020
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

2371×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

Refusal History

DateProductViolationsDivision
11/2/2020
83QKOREAGENT, CORONAVIRUS SEROLOGICAL
237NO PMA
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Core Technology Co. Ltd.'s FDA import refusal history?

Core Technology Co. Ltd. (FEI: 3008054239) has 1 FDA import refusal record(s) in our database, spanning from 11/2/2020 to 11/2/2020.

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. Core Technology Co. Ltd.'s FEI number is 3008054239.

What types of violations has Core Technology Co. Ltd. received?

Core 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 Core Technology Co. Ltd. come from?

All FDA import refusal data for Core 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.