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3lab, Inc

⚠️ Moderate Risk

FEI: 3009036456 • Englewood, NJ • UNITED STATES

FEI

FEI Number

3009036456

📍

Location

Englewood, NJ

🇺🇸
🏢

Address

100 W Sheffield Ave, , Englewood, NJ, United States

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
7/28/2011
Latest Refusal
7/28/2011
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
7/28/2011
66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
New York District Office (NYK-DO)
7/28/2011
66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
New York District Office (NYK-DO)
7/28/2011
66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
New York District Office (NYK-DO)

Frequently Asked Questions

What is 3lab, Inc's FDA import refusal history?

3lab, Inc (FEI: 3009036456) has 3 FDA import refusal record(s) in our database, spanning from 7/28/2011 to 7/28/2011.

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. 3lab, Inc's FEI number is 3009036456.

What types of violations has 3lab, Inc received?

3lab, 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 3lab, Inc come from?

All FDA import refusal data for 3lab, 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.