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SCOTLE TECHNOLOGY GROUP LTD

⚠️ Moderate Risk

FEI: 3013518632 • Shenzhen • CHINA

FEI

FEI Number

3013518632

📍

Location

Shenzhen

🇨🇳

Country

CHINA
🏢

Address

First Fl A, # Dormitory, Shenzhen, , 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
6/9/2017
Latest Refusal
6/9/2017
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

1261×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

Refusal History

DateProductViolationsDivision
6/9/2017
95RZNGENERAL INDUSTRIAL USE MATERIAL PROCESSING LASER PRODUCTS
126FAILS STD
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SCOTLE TECHNOLOGY GROUP LTD's FDA import refusal history?

SCOTLE TECHNOLOGY GROUP LTD (FEI: 3013518632) has 1 FDA import refusal record(s) in our database, spanning from 6/9/2017 to 6/9/2017.

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. SCOTLE TECHNOLOGY GROUP LTD's FEI number is 3013518632.

What types of violations has SCOTLE TECHNOLOGY GROUP LTD received?

SCOTLE TECHNOLOGY GROUP 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 SCOTLE TECHNOLOGY GROUP LTD come from?

All FDA import refusal data for SCOTLE TECHNOLOGY GROUP 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.