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BEIJING NORTH INST

⚠️ Moderate Risk

FEI: 3017760876 • Beijing • CHINA

FEI

FEI Number

3017760876

📍

Location

Beijing

🇨🇳

Country

CHINA
🏢

Address

# 20 Panjiamiao Fen, , 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
2
Unique Violations
3/21/2022
Latest Refusal
3/21/2022
Earliest Refusal

Score Breakdown

Violation Severity
75.0×40%
Refusal Volume
11.2×30%
Recency
9.7×20%
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).

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
3/21/2022
83QKOREAGENT, CORONAVIRUS SEROLOGICAL
237NO PMA
508NO 510(K)
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is BEIJING NORTH INST's FDA import refusal history?

BEIJING NORTH INST (FEI: 3017760876) has 1 FDA import refusal record(s) in our database, spanning from 3/21/2022 to 3/21/2022.

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. BEIJING NORTH INST's FEI number is 3017760876.

What types of violations has BEIJING NORTH INST received?

BEIJING NORTH INST 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 BEIJING NORTH INST come from?

All FDA import refusal data for BEIJING NORTH INST 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.