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Beijing KES Biology Technology Co., Ltd.

⚠️ Moderate Risk

FEI: 3009444646 • Beijing, Beijing • CHINA

FEI

FEI Number

3009444646

📍

Location

Beijing, Beijing

🇨🇳

Country

CHINA
🏢

Address

No.15, Zone 2, Mafang Industrial Park, Pingguyuan Zhongguancun Science And Technology Park, Pinggu District, , Beijing, Beijing, China

Moderate Risk

FDA Import Risk Assessment

27.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
6/21/2016
Latest Refusal
9/18/2015
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

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
6/21/2016
79ONFPOWERED LIGHT BASED NON-LASER SURGICAL INSTRUMENT WITH THERMAL EFFECT
508NO 510(K)
Cincinnati District Office (CIN-DO)
9/18/2015
79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL
341REGISTERED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Beijing KES Biology Technology Co., Ltd.'s FDA import refusal history?

Beijing KES Biology Technology Co., Ltd. (FEI: 3009444646) has 2 FDA import refusal record(s) in our database, spanning from 9/18/2015 to 6/21/2016.

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 KES Biology Technology Co., Ltd.'s FEI number is 3009444646.

What types of violations has Beijing KES Biology Technology Co., Ltd. received?

Beijing KES Biology 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 Beijing KES Biology Technology Co., Ltd. come from?

All FDA import refusal data for Beijing KES Biology 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.