CARAPEX INC
⚠️ Moderate Risk
FEI: 3013929968 • Chambly, Quebec • CANADA
FEI Number
3013929968
Location
Chambly, Quebec
Country
CANADAAddress
2315 Industriel Blvd, , Chambly, 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
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.
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 |
|---|---|---|---|
| 12/20/2017 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Northern Border Imports (DNBI) |
| 12/20/2017 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Northern Border Imports (DNBI) |
| 12/20/2017 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Northern Border Imports (DNBI) |
| 12/20/2017 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Northern Border Imports (DNBI) |
| 12/20/2017 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 12/20/2017 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 12/20/2017 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 12/20/2017 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is CARAPEX INC's FDA import refusal history?
CARAPEX INC (FEI: 3013929968) has 8 FDA import refusal record(s) in our database, spanning from 12/20/2017 to 12/20/2017.
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. CARAPEX INC's FEI number is 3013929968.
What types of violations has CARAPEX INC received?
CARAPEX INC has been cited for 2 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 CARAPEX INC come from?
All FDA import refusal data for CARAPEX 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.