Urist Cosmetics Inc
⚠️ Moderate Risk
FEI: 3001549937 • Richmond, British Columbia • CANADA
FEI Number
3001549937
Location
Richmond, British Columbia
Country
CANADAAddress
1167-11871 Horseshoe Way, , Richmond, British Columbia, 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
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).
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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/18/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Seattle District Office (SEA-DO) | |
| 5/25/2012 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 9/12/2011 | 61HAJ99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 7/8/2011 | 63VBY99DEPIGMENTOR N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 4/8/2011 | 79MDAELASTOMER, SILICONE, FOR SCAR MANAGEMENT | Seattle District Office (SEA-DO) | |
| 11/9/2010 | 65CBL04BETAINE ANHYDROUS (NUTRIENT/TONIC) | Los Angeles District Office (LOS-DO) | |
| 11/16/2009 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 8/1/2005 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/14/2003 | 64GBJ99ESTROGEN N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Urist Cosmetics Inc's FDA import refusal history?
Urist Cosmetics Inc (FEI: 3001549937) has 9 FDA import refusal record(s) in our database, spanning from 11/14/2003 to 9/18/2012.
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. Urist Cosmetics Inc's FEI number is 3001549937.
What types of violations has Urist Cosmetics Inc received?
Urist Cosmetics Inc has been cited for 4 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 Urist Cosmetics Inc come from?
All FDA import refusal data for Urist Cosmetics 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.