SV Labs Toronto Corporation
⚠️ High Risk
FEI: 3010476347 • Brampton, Ontario • CANADA
FEI Number
3010476347
Location
Brampton, Ontario
Country
CANADAAddress
296 Orenda Rd, , Brampton, Ontario, Canada
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
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
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).
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.
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).
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
FALSE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
VET LEGEND
The article appears to be a veterinary drug without the "Caution" statement as required by Section 503(f)(4).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/3/2018 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 5/15/2014 | 55QG64PROPYLENE GLYCOL (PHARMACEUTIC NECESSITY - SOLVENT) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/12/2013 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 260FALSE | Detroit District Office (DET-DO) |
| 6/21/2013 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/29/2011 | 61XBJ99ANTI-HISTAMINIC N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 9/29/2011 | 61XBJ99ANTI-HISTAMINIC N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 8/18/2011 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 7/19/2011 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 7/11/2011 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 7/11/2011 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 7/11/2011 | 53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 7/11/2011 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 7/7/2011 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 6/30/2011 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 6/30/2011 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 6/27/2011 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 6/27/2011 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 6/27/2011 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 6/17/2011 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Detroit District Office (DET-DO) | |
| 6/17/2011 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 6/17/2011 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 6/17/2011 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 6/17/2011 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 6/17/2011 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 6/17/2011 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 6/2/2011 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 4/14/2011 | 64PMK99HEMOSTATIC N.E.C. | Detroit District Office (DET-DO) | |
| 4/13/2011 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 6/15/2010 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 473LABELING | New York District Office (NYK-DO) |
| 6/15/2010 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 473LABELING | New York District Office (NYK-DO) |
| 3/11/2010 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 3/5/2010 | 53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 3/5/2010 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 3/5/2010 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 3/5/2010 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 3/5/2010 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 3/3/2010 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 12/18/2009 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 12/18/2009 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 11/9/2009 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 11/9/2009 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 11/9/2009 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 11/9/2009 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 11/9/2009 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 11/9/2009 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 11/9/2009 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 11/9/2009 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 11/9/2009 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 11/9/2009 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 11/9/2009 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 9/22/2009 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | New York District Office (NYK-DO) |
| 9/22/2009 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | New York District Office (NYK-DO) |
| 6/9/2009 | 64ABL20TRICLOSAN (DISINFECTANT) | New York District Office (NYK-DO) | |
| 12/31/2007 | 62NBL99ANTI-PSORIATIC N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is SV Labs Toronto Corporation's FDA import refusal history?
SV Labs Toronto Corporation (FEI: 3010476347) has 54 FDA import refusal record(s) in our database, spanning from 12/31/2007 to 10/3/2018.
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. SV Labs Toronto Corporation's FEI number is 3010476347.
What types of violations has SV Labs Toronto Corporation received?
SV Labs Toronto Corporation 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 SV Labs Toronto Corporation come from?
All FDA import refusal data for SV Labs Toronto Corporation 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.