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NEUROSTYLE PTE LT

⚠️ Moderate Risk

FEI: 3014806498 • Singapore • SINGAPORE

FEI

FEI Number

3014806498

📍

Location

Singapore

🇸🇬

Country

SINGAPORE
🏢

Address

63 Hillview Avenue, Lam Soon Industrial Building, Singapore, , Singapore

Moderate Risk

FDA Import Risk Assessment

29.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
6/4/2019
Latest Refusal
6/4/2019
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

1183×

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
6/4/2019
87HXBPROBE
118NOT LISTED
Division of Southeast Imports (DSEI)
6/4/2019
79GABNEEDLE, SUTURING, DISPOSABLE
118NOT LISTED
Division of Southeast Imports (DSEI)
6/4/2019
78KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES)
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is NEUROSTYLE PTE LT's FDA import refusal history?

NEUROSTYLE PTE LT (FEI: 3014806498) has 3 FDA import refusal record(s) in our database, spanning from 6/4/2019 to 6/4/2019.

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. NEUROSTYLE PTE LT's FEI number is 3014806498.

What types of violations has NEUROSTYLE PTE LT received?

NEUROSTYLE PTE LT 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 NEUROSTYLE PTE LT come from?

All FDA import refusal data for NEUROSTYLE PTE LT 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.