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AKELA LASER CORP

⚠️ Moderate Risk

FEI: 3013138216 • Monroe Township, NJ • UNITED STATES

FEI

FEI Number

3013138216

📍

Location

Monroe Township, NJ

🇺🇸
🏢

Address

1095 Cranbury South River Rd, , Monroe Township, NJ, United States

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
7/21/2020
Latest Refusal
7/21/2020
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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.

4761×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

Refusal History

DateProductViolationsDivision
7/21/2020
95RAALASER PRODUCTS (PRE-STANDARD)
126FAILS STD
476NO REGISTR
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is AKELA LASER CORP's FDA import refusal history?

AKELA LASER CORP (FEI: 3013138216) has 1 FDA import refusal record(s) in our database, spanning from 7/21/2020 to 7/21/2020.

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. AKELA LASER CORP's FEI number is 3013138216.

What types of violations has AKELA LASER CORP received?

AKELA LASER CORP has been cited for 2 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 AKELA LASER CORP come from?

All FDA import refusal data for AKELA LASER CORP 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.