Canderm Pharma Ltd.
⚠️ Moderate Risk
FEI: 1000639358 • Saint-Laurent, Quebec • CANADA
FEI Number
1000639358
Location
Saint-Laurent, Quebec
Country
CANADAAddress
5353 Thimens Blvd, , Saint-Laurent, 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
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).
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 |
|---|---|---|---|
| 12/14/2007 | 60QCY99ANESTHETIC, N.E.C. | New Orleans District Office (NOL-DO) | |
| 5/31/2006 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | New York District Office (NYK-DO) |
| 12/13/2004 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Canderm Pharma Ltd.'s FDA import refusal history?
Canderm Pharma Ltd. (FEI: 1000639358) has 3 FDA import refusal record(s) in our database, spanning from 12/13/2004 to 12/14/2007.
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. Canderm Pharma Ltd.'s FEI number is 1000639358.
What types of violations has Canderm Pharma Ltd. received?
Canderm Pharma Ltd. has been cited for 3 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 Canderm Pharma Ltd. come from?
All FDA import refusal data for Canderm Pharma Ltd. 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.