Recherche Go Vitality Go

⚠️ Moderate Risk

FEI: 3005460808 • Otterburn, QUEBEC • CANADA

FEI

FEI Number

3005460808

📍

Location

Otterburn, QUEBEC

🇨🇦

Country

CANADA

🏢

Address

801 Ch Ozlaz Leduc, , Otterburn, QUEBEC, Canada

Moderate Risk

FDA Import Risk Assessment

42.9

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

9/29/2006

Latest Refusal

9/29/2006

Earliest Refusal

Score Breakdown

Violation Severity

53.3×40%

Refusal Volume

38.6×30%

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

11810×

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).

1610×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

47310×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

Date	Product	Violations	Division
9/29/2006	61HBY99ANTI-BACTERIAL, N.E.C.	118NOT LISTED 16DIRECTIONS 473LABELING	New York District Office (NYK-DO)
9/29/2006	61HBY99ANTI-BACTERIAL, N.E.C.	118NOT LISTED 16DIRECTIONS 473LABELING	New York District Office (NYK-DO)
9/29/2006	61HBY99ANTI-BACTERIAL, N.E.C.	118NOT LISTED 16DIRECTIONS 473LABELING	New York District Office (NYK-DO)
9/29/2006	61HBY99ANTI-BACTERIAL, N.E.C.	118NOT LISTED 16DIRECTIONS 473LABELING	New York District Office (NYK-DO)
9/29/2006	61HBY99ANTI-BACTERIAL, N.E.C.	118NOT LISTED 16DIRECTIONS 473LABELING	New York District Office (NYK-DO)
9/29/2006	61HBY99ANTI-BACTERIAL, N.E.C.	118NOT LISTED 16DIRECTIONS 473LABELING	New York District Office (NYK-DO)
9/29/2006	61HBY99ANTI-BACTERIAL, N.E.C.	118NOT LISTED 16DIRECTIONS 473LABELING	New York District Office (NYK-DO)
9/29/2006	61HBY99ANTI-BACTERIAL, N.E.C.	118NOT LISTED 16DIRECTIONS 473LABELING	New York District Office (NYK-DO)
9/29/2006	61HBY99ANTI-BACTERIAL, N.E.C.	118NOT LISTED 16DIRECTIONS 473LABELING	New York District Office (NYK-DO)
9/29/2006	61HBY99ANTI-BACTERIAL, N.E.C.	118NOT LISTED 16DIRECTIONS 473LABELING	New York District Office (NYK-DO)

Frequently Asked Questions

What is Recherche Go Vitality Go's FDA import refusal history?

Recherche Go Vitality Go (FEI: 3005460808) has 10 FDA import refusal record(s) in our database, spanning from 9/29/2006 to 9/29/2006.

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. Recherche Go Vitality Go's FEI number is 3005460808.

What types of violations has Recherche Go Vitality Go received?

Recherche Go Vitality Go has been cited for 3 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 Recherche Go Vitality Go come from?

All FDA import refusal data for Recherche Go Vitality Go 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.