Dermolab Pharma Ltd.
⚠️ Moderate Risk
FEI: 3003011816 • Sainte-Julie, Quebec • CANADA
FEI Number
3003011816
Location
Sainte-Julie, Quebec
Country
CANADAAddress
1421 Nobel St, , Sainte-Julie, 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).
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).
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
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.
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.
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/17/2018 | 66PBY18ZINC OXIDE (ULTRAVIOLET SCREEN/SUNSCREEN) | Division of Northern Border Imports (DNBI) | |
| 9/17/2018 | 66PBY18ZINC OXIDE (ULTRAVIOLET SCREEN/SUNSCREEN) | Division of Northern Border Imports (DNBI) | |
| 11/20/2017 | 53LG10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 3/24/2016 | 66YAJ99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Cincinnati District Office (CIN-DO) | |
| 3/24/2016 | 66YAJ99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Cincinnati District Office (CIN-DO) | |
| 3/24/2016 | 65LBJ99PROTECTANT N.E.C. | Cincinnati District Office (CIN-DO) | |
| 3/24/2016 | 66YAJ99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Cincinnati District Office (CIN-DO) | |
| 3/23/2016 | 53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | Cincinnati District Office (CIN-DO) | |
| 3/23/2016 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | Cincinnati District Office (CIN-DO) | |
| 3/8/2016 | 66YAJ99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Cincinnati District Office (CIN-DO) | |
| 2/29/2016 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Cincinnati District Office (CIN-DO) | |
| 2/29/2016 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 2/29/2016 | 16YHI18BROTH, SEAFOOD (N.E.C.), FISHERY PRODUCTS, N.E.C. | 83NO PROCESS | New York District Office (NYK-DO) |
| 2/29/2016 | 38MHI03BEEF BROTH, PLAIN (MEAT AND/OR VEGETABLE STOCK) | 83NO PROCESS | New York District Office (NYK-DO) |
| 1/30/2015 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 1/30/2015 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 6/28/2010 | 54GCL01BOVINE (COW, ETC.) (ANIMAL BY-PRODUCTS AND EXTRACTS) | 83NO PROCESS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Dermolab Pharma Ltd.'s FDA import refusal history?
Dermolab Pharma Ltd. (FEI: 3003011816) has 17 FDA import refusal record(s) in our database, spanning from 6/28/2010 to 9/17/2018.
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. Dermolab Pharma Ltd.'s FEI number is 3003011816.
What types of violations has Dermolab Pharma Ltd. received?
Dermolab Pharma Ltd. has been cited for 8 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 Dermolab Pharma Ltd. come from?
All FDA import refusal data for Dermolab 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.