ImportRefusal LogoImportRefusal

Beijing Global IPL Development Co, LTD.

⚠️ Moderate Risk

FEI: 3013243668 • Beijing • CHINA

FEI

FEI Number

3013243668

📍

Location

Beijing

🇨🇳

Country

CHINA
🏢

Address

Room 801, Qunyinghui Research Bldg., No 32 JinYuan Rd, DaXing Eco Dev Zn, Beijing, , China

Moderate Risk

FDA Import Risk Assessment

35.6
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
3/22/2023
Latest Refusal
3/22/2023
Earliest Refusal

Score Breakdown

Violation Severity
63.3×40%
Refusal Volume
11.2×30%
Recency
29.8×20%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

471×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

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
3/22/2023
79GEXPOWERED LASER SURGICAL INSTRUMENTS
118NOT LISTED
47NON STD
508NO 510(K)
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Beijing Global IPL Development Co, LTD.'s FDA import refusal history?

Beijing Global IPL Development Co, LTD. (FEI: 3013243668) has 1 FDA import refusal record(s) in our database, spanning from 3/22/2023 to 3/22/2023.

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. Beijing Global IPL Development Co, LTD.'s FEI number is 3013243668.

What types of violations has Beijing Global IPL Development Co, LTD. received?

Beijing Global IPL Development Co, LTD. has been cited for 3 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 Global IPL Development Co, LTD. come from?

All FDA import refusal data for Beijing Global IPL Development 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.