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AccelLAB, Inc.

⚠️ Moderate Risk

FEI: 3005483765 • Boisbriand, Quebec • CANADA

FEI

FEI Number

3005483765

📍

Location

Boisbriand, Quebec

🇨🇦

Country

CANADA
🏢

Address

1635 Lionel-Bertrand Blvd, , Boisbriand, Quebec, Canada

Moderate Risk

FDA Import Risk Assessment

30.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
10/21/2006
Latest Refusal
10/21/2006
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
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

1181×

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).

2371×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

Refusal History

DateProductViolationsDivision
10/21/2006
74NIQSTENT, CORONARY, DRUG-ELUTING
118NOT LISTED
237NO PMA
New Orleans District Office (NOL-DO)

Frequently Asked Questions

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

AccelLAB, Inc. (FEI: 3005483765) has 1 FDA import refusal record(s) in our database, spanning from 10/21/2006 to 10/21/2006.

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. AccelLAB, Inc.'s FEI number is 3005483765.

What types of violations has AccelLAB, Inc. received?

AccelLAB, Inc. 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 AccelLAB, Inc. come from?

All FDA import refusal data for AccelLAB, 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.