Cosmetica Laboratories Inc.
⚠️ Moderate Risk
FEI: 3002759716 • Scarborough, Ontario • CANADA
FEI Number
3002759716
Location
Scarborough, Ontario
Country
CANADAAddress
1960 Eglinton Ave E, , Scarborough, 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
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.
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).
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.
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).
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/20/2013 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 2/20/2013 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 2/20/2013 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 2/20/2013 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 11/14/2011 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 11/14/2011 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 11/14/2011 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 11/14/2011 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 8/20/2010 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | New York District Office (NYK-DO) |
| 1/5/2009 | 62FBJ99ANTI-INFECTIVE, TOPICAL N.E.C. | New York District Office (NYK-DO) | |
| 8/23/2004 | 53RY03EYE MAKE UP PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (BOVINE) | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
| 12/30/2003 | 53GH01BLUSHERS (ALL TYPES) (MAKEUP PREPARATIONS, NOT FOR EYES) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 12/30/2003 | 53GH01BLUSHERS (ALL TYPES) (MAKEUP PREPARATIONS, NOT FOR EYES) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 11/19/2003 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Cosmetica Laboratories Inc.'s FDA import refusal history?
Cosmetica Laboratories Inc. (FEI: 3002759716) has 14 FDA import refusal record(s) in our database, spanning from 11/19/2003 to 2/20/2013.
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. Cosmetica Laboratories Inc.'s FEI number is 3002759716.
What types of violations has Cosmetica Laboratories Inc. received?
Cosmetica Laboratories Inc. has been cited for 6 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 Cosmetica Laboratories Inc. come from?
All FDA import refusal data for Cosmetica Laboratories 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.