Zengar Institute Inc

⚠️ High Risk

FEI: 3011139332 • L'Ile-Perrot, Quebec • CANADA

FEI

FEI Number

3011139332

📍

Location

L'Ile-Perrot, Quebec

🇨🇦

Country

CANADA

🏢

Address

545A Grand Blvd, , L'Ile-Perrot, Quebec, Canada

High Risk

FDA Import Risk Assessment

51.3

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

10/26/2017

Latest Refusal

6/23/2016

Earliest Refusal

Score Breakdown

Violation Severity

58.4×40%

Refusal Volume

59.7×30%

Recency

0.0×20%

Frequency

100.0×10%

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

Violation Summary

50837×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

11831×

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).

328031×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

2373×

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).

23801×

NO PMA/PDP

The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).

Refusal History

Date	Product	Violations	Division
10/26/2017	80PEQACCESSORIES TO EXAMINATION LIGHT	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
10/26/2017	84HCCDEVICE, BIOFEEDBACK	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
10/25/2017	84HCCDEVICE, BIOFEEDBACK	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
10/13/2017	84HCCDEVICE, BIOFEEDBACK	508NO 510(K)	Division of Southeast Imports (DSEI)
9/29/2017	84HCCDEVICE, BIOFEEDBACK	508NO 510(K)	Division of Southeast Imports (DSEI)
9/22/2017	84HCCDEVICE, BIOFEEDBACK	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
9/22/2017	84HCCDEVICE, BIOFEEDBACK	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
9/20/2017	84HCCDEVICE, BIOFEEDBACK	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
9/20/2017	84HCCDEVICE, BIOFEEDBACK	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
9/14/2017	84HCCDEVICE, BIOFEEDBACK	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
9/13/2017	84HCCDEVICE, BIOFEEDBACK	508NO 510(K)	Division of Southeast Imports (DSEI)
9/13/2017	84HCCDEVICE, BIOFEEDBACK	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
8/23/2017	84HCCDEVICE, BIOFEEDBACK	508NO 510(K)	Division of Southeast Imports (DSEI)
8/21/2017	84HCCDEVICE, BIOFEEDBACK	508NO 510(K)	Division of Southeast Imports (DSEI)
8/21/2017	84HCCDEVICE, BIOFEEDBACK	508NO 510(K)	Division of Southeast Imports (DSEI)
8/16/2017	84HCCDEVICE, BIOFEEDBACK	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
8/16/2017	84HCCDEVICE, BIOFEEDBACK	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
8/15/2017	84HCCDEVICE, BIOFEEDBACK	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
7/7/2017	84HCCDEVICE, BIOFEEDBACK	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
7/7/2017	84HCCDEVICE, BIOFEEDBACK	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
7/7/2017	84HCCDEVICE, BIOFEEDBACK	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
7/7/2017	84HCCDEVICE, BIOFEEDBACK	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
7/7/2017	84HCCDEVICE, BIOFEEDBACK	118NOT LISTED 237NO PMA 3280FRNMFGREG	Division of Southeast Imports (DSEI)
6/28/2017	84GYBMEDIA, ELECTROCONDUCTIVE	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
6/28/2017	84GYBMEDIA, ELECTROCONDUCTIVE	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
6/28/2017	84HCCDEVICE, BIOFEEDBACK	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
6/28/2017	84HCCDEVICE, BIOFEEDBACK	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
6/28/2017	84HCCDEVICE, BIOFEEDBACK	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
6/28/2017	84HCCDEVICE, BIOFEEDBACK	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
6/28/2017	84HCCDEVICE, BIOFEEDBACK	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
6/22/2017	84HCCDEVICE, BIOFEEDBACK	508NO 510(K)	Division of Southeast Imports (DSEI)
6/22/2017	84HCCDEVICE, BIOFEEDBACK	508NO 510(K)	Division of Southeast Imports (DSEI)
6/20/2017	84HCCDEVICE, BIOFEEDBACK	237NO PMA	Division of Southeast Imports (DSEI)
6/8/2017	84HCCDEVICE, BIOFEEDBACK	118NOT LISTED 237NO PMA 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
5/10/2017	84HCCDEVICE, BIOFEEDBACK	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
3/31/2017	84HCCDEVICE, BIOFEEDBACK	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
3/31/2017	84HCCDEVICE, BIOFEEDBACK	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
3/2/2017	84HCCDEVICE, BIOFEEDBACK	118NOT LISTED 2380NO PMA/PDP 3280FRNMFGREG	New Orleans District Office (NOL-DO)
1/17/2017	84HCCDEVICE, BIOFEEDBACK	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
6/23/2016	84GWQELECTROENCEPHALOGRAPH	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Zengar Institute Inc's FDA import refusal history?

Zengar Institute Inc (FEI: 3011139332) has 40 FDA import refusal record(s) in our database, spanning from 6/23/2016 to 10/26/2017.

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. Zengar Institute Inc's FEI number is 3011139332.

What types of violations has Zengar Institute Inc received?

Zengar Institute Inc has been cited for 5 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 Zengar Institute Inc come from?

All FDA import refusal data for Zengar Institute 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.