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Shenzhen Baiyongtong Technology Development Co Ltd

⚠️ Moderate Risk

FEI: 3009574812 • Shenzhen • HONG KONG

FEI

FEI Number

3009574812

📍

Location

Shenzhen

🇭🇰

Country

HONG KONG
🏢

Address

21a Building 4 Xiandaicheng Huating, , Shenzhen, , Hong Kong

Moderate Risk

FDA Import Risk Assessment

35.4
LowModerateHighCritical

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

Statistics

6
Total Refusals
1
Unique Violations
11/27/2012
Latest Refusal
11/27/2012
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

1186×

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).

Refusal History

DateProductViolationsDivision
11/27/2012
60LAO99ANALGESIC, N.E.C.
118NOT LISTED
Los Angeles District Office (LOS-DO)
11/27/2012
60LAO99ANALGESIC, N.E.C.
118NOT LISTED
Los Angeles District Office (LOS-DO)
11/27/2012
60LAO99ANALGESIC, N.E.C.
118NOT LISTED
Los Angeles District Office (LOS-DO)
11/27/2012
60LAO99ANALGESIC, N.E.C.
118NOT LISTED
Los Angeles District Office (LOS-DO)
11/27/2012
60LAO99ANALGESIC, N.E.C.
118NOT LISTED
Los Angeles District Office (LOS-DO)
11/27/2012
60LAO99ANALGESIC, N.E.C.
118NOT LISTED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Shenzhen Baiyongtong Technology Development Co Ltd's FDA import refusal history?

Shenzhen Baiyongtong Technology Development Co Ltd (FEI: 3009574812) has 6 FDA import refusal record(s) in our database, spanning from 11/27/2012 to 11/27/2012.

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 Baiyongtong Technology Development Co Ltd's FEI number is 3009574812.

What types of violations has Shenzhen Baiyongtong Technology Development Co Ltd received?

Shenzhen Baiyongtong Technology Development 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 Baiyongtong Technology Development Co Ltd come from?

All FDA import refusal data for Shenzhen Baiyongtong Technology 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.