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SWG Labs, Inc.

⚠️ Moderate Risk

FEI: 3003963141 • Las Vegas, NV • UNITED STATES

FEI

FEI Number

3003963141

📍

Location

Las Vegas, NV

🇺🇸
🏢

Address

4220 W Windmill Ln Ste 140, , Las Vegas, NV, United States

Moderate Risk

FDA Import Risk Assessment

27.8
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/1/2023
Latest Refusal
12/1/2023
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
57.2×20%
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

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).

Refusal History

DateProductViolationsDivision
12/1/2023
85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SWG Labs, Inc.'s FDA import refusal history?

SWG Labs, Inc. (FEI: 3003963141) has 1 FDA import refusal record(s) in our database, spanning from 12/1/2023 to 12/1/2023.

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. SWG Labs, Inc.'s FEI number is 3003963141.

What types of violations has SWG Labs, Inc. received?

SWG Labs, Inc. 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 SWG Labs, Inc. come from?

All FDA import refusal data for SWG Labs, Inc. 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.