Laboratoire du-Var Inc.

⚠️ High Risk

FEI: 3002449500 • Boucherville, Quebec • CANADA

FEI

FEI Number

3002449500

📍

Location

Boucherville, Quebec

🇨🇦

Country

CANADA

🏢

Address

1460 Graham-bell St, , Boucherville, Quebec, Canada

High Risk

FDA Import Risk Assessment

54.2

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

12/19/2025

Latest Refusal

5/9/2005

Earliest Refusal

Score Breakdown

Violation Severity

53.6×40%

Refusal Volume

46.5×30%

Recency

89.9×20%

Frequency

8.2×10%

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

1187×

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).

757×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

3356×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

4734×

LABELING

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

4712×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

162×

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.

3332×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

4742×

COSMETLBLG

It appears the label does not bear the common or usual name of the cosmetic.

4752×

COSMETLBLG

It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.

2231×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

1781×

COL ADDED

The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).

Refusal History

Date	Product	Violations	Division
12/19/2025	60LAJ99ANALGESIC, N.E.C.	75UNAPPROVED	Division of Southeast Imports (DSEI)
12/14/2025	60LBY99ANALGESIC, N.E.C.	75UNAPPROVED	Division of Southeast Imports (DSEI)
4/13/2018	53KC99OTHER SHAVING PREPARATION PRODUCTS, N.E.C.	75UNAPPROVED	Division of Northern Border Imports (DNBI)
4/13/2018	53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.	75UNAPPROVED	Division of Northern Border Imports (DNBI)
4/17/2014	64XBJ06SALICYLIC ACID (KERATOLYTIC)	118NOT LISTED 16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
6/6/2013	53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	333LACKS FIRM 473LABELING 75UNAPPROVED	New York District Office (NYK-DO)
6/6/2013	53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	333LACKS FIRM 473LABELING 75UNAPPROVED	New York District Office (NYK-DO)
11/2/2009	62HAL99ANTI-MICROBIAL N.E.C.	118NOT LISTED 335LACKS N/C	New York District Office (NYK-DO)
11/2/2009	62HAL99ANTI-MICROBIAL N.E.C.	118NOT LISTED 335LACKS N/C	New York District Office (NYK-DO)
11/2/2009	62HAL99ANTI-MICROBIAL N.E.C.	118NOT LISTED 335LACKS N/C	New York District Office (NYK-DO)
11/2/2009	64AAL99DISINFECTANT N.E.C.	118NOT LISTED 335LACKS N/C	New York District Office (NYK-DO)
11/2/2009	64AAL99DISINFECTANT N.E.C.	118NOT LISTED 335LACKS N/C	New York District Office (NYK-DO)
11/2/2009	64AAL99DISINFECTANT N.E.C.	118NOT LISTED 335LACKS N/C	New York District Office (NYK-DO)
7/16/2007	53LD06MOISTURIZING (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Detroit District Office (DET-DO)
7/16/2007	53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Detroit District Office (DET-DO)
5/18/2006	62MBJ09LIQUID PHENOL (ANTI-PRURITIC)	16DIRECTIONS 223FALSE	New York District Office (NYK-DO)
5/9/2005	62MBJ09LIQUID PHENOL (ANTI-PRURITIC)	178COL ADDED	New York District Office (NYK-DO)

Frequently Asked Questions

What is Laboratoire du-Var Inc.'s FDA import refusal history?

Laboratoire du-Var Inc. (FEI: 3002449500) has 17 FDA import refusal record(s) in our database, spanning from 5/9/2005 to 12/19/2025.

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. Laboratoire du-Var Inc.'s FEI number is 3002449500.

What types of violations has Laboratoire du-Var Inc. received?

Laboratoire du-Var Inc. has been cited for 11 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 Laboratoire du-Var Inc. come from?

All FDA import refusal data for Laboratoire du-Var 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.