Vivier Pharma, Inc.
⚠️ Moderate Risk
FEI: 3003198686 • Vaudreuil-Dorion, Quebec • CANADA
FEI Number
3003198686
Location
Vaudreuil-Dorion, Quebec
Country
CANADAAddress
288 Adrien-Patenaude St, , Vaudreuil-Dorion, Quebec, 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
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).
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.
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).
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
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.
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.
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) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/30/2006 | 53LY09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 12/15/2005 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New Orleans District Office (NOL-DO) | |
| 10/3/2005 | 61HBL99ANTI-BACTERIAL, N.E.C. | New York District Office (NYK-DO) | |
| 9/12/2005 | 61HBL99ANTI-BACTERIAL, N.E.C. | New York District Office (NYK-DO) | |
| 3/28/2005 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
| 3/28/2005 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
| 3/28/2005 | 53LY01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
| 3/28/2005 | 53LY01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
| 3/28/2005 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 3/28/2005 | 53RC13SUNTAN PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (BOVINE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/3/2005 | 66VIL99MISCELLANEOUS PATENT MEDICINES, ETC. | 223FALSE | New Orleans District Office (NOL-DO) |
| 11/19/2004 | 65QDL99RELAXANT N.E.C. | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Vivier Pharma, Inc.'s FDA import refusal history?
Vivier Pharma, Inc. (FEI: 3003198686) has 12 FDA import refusal record(s) in our database, spanning from 11/19/2004 to 10/30/2006.
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. Vivier Pharma, Inc.'s FEI number is 3003198686.
What types of violations has Vivier Pharma, Inc. received?
Vivier Pharma, Inc. has been cited for 9 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 Vivier Pharma, Inc. come from?
All FDA import refusal data for Vivier Pharma, 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.