Voyant Beauty, Inc.
⚠️ Moderate Risk
FEI: 1000251162 • Etobicoke, Ontario • CANADA
FEI Number
1000251162
Location
Etobicoke, Ontario
Country
CANADAAddress
2000 Kipling Ave, , Etobicoke, Ontario, Canada
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
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).
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).
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.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
DR QUALITC
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
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.
FILTH
The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that the article contains potentially hazardous, or otherwise objectionable in light of intended use, microbial adulteration and therefore consists in part of a filthy substance
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/8/2023 | 64XAY03BENZOYL PEROXIDE (KERATOLYTIC) | 3761FILTH | Division of Northern Border Imports (DNBI) |
| 5/8/2012 | 66PBY05HOMOSALATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 336INCONSPICU | Detroit District Office (DET-DO) |
| 4/9/2012 | 64XBL06SALICYLIC ACID (KERATOLYTIC) | Detroit District Office (DET-DO) | |
| 4/9/2012 | 64XAS06SALICYLIC ACID (KERATOLYTIC) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 12/12/2011 | 64XBY06SALICYLIC ACID (KERATOLYTIC) | New Orleans District Office (NOL-DO) | |
| 12/7/2011 | 53KC05SHAVING CREAM (AEROSOL, BRUSHLESS, LATHER) (SHAVING PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 7/15/2011 | 62MBL99ANTI-PRURITIC N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 6/24/2011 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 6/8/2011 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/4/2011 | 53LY01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 12/18/2009 | 64XAL03BENZOYL PEROXIDE (KERATOLYTIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 12/18/2009 | 64XAL03BENZOYL PEROXIDE (KERATOLYTIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/16/2009 | 65LAY99PROTECTANT N.E.C. | New York District Office (NYK-DO) | |
| 3/30/2009 | 53LA01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/30/2009 | 64XAL06SALICYLIC ACID (KERATOLYTIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/29/2006 | 53LY01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 6/14/2005 | 64XBL06SALICYLIC ACID (KERATOLYTIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/6/2002 | 61HAJ99ANTI-BACTERIAL, N.E.C. | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Voyant Beauty, Inc.'s FDA import refusal history?
Voyant Beauty, Inc. (FEI: 1000251162) has 18 FDA import refusal record(s) in our database, spanning from 8/6/2002 to 9/8/2023.
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. Voyant Beauty, Inc.'s FEI number is 1000251162.
What types of violations has Voyant Beauty, Inc. received?
Voyant Beauty, 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 Voyant Beauty, Inc. come from?
All FDA import refusal data for Voyant Beauty, 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.