Lab Delon Y/O Iris B/S
⚠️ Moderate Risk
FEI: 3008714618 • Dollard-des-ormeaux, QC • CANADA
FEI Number
3008714618
Location
Dollard-des-ormeaux, QC
Country
CANADAAddress
69 Boul Brunswick, , Dollard-des-ormeaux, QC, 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
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/6/2012 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 473LABELING | San Juan District Office (SJN-DO) |
| 7/6/2012 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 473LABELING | San Juan District Office (SJN-DO) |
| 7/6/2012 | 53JF99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C. | 473LABELING | San Juan District Office (SJN-DO) |
| 7/6/2012 | 53JF99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C. | 473LABELING | San Juan District Office (SJN-DO) |
| 7/6/2012 | 55RY99PHARMACEUTIC NECESSITIES, N.E.C. | 223FALSE | San Juan District Office (SJN-DO) |
| 7/6/2012 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 198COLOR LBLG | San Juan District Office (SJN-DO) |
| 7/6/2012 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 198COLOR LBLG | San Juan District Office (SJN-DO) |
| 7/6/2012 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 198COLOR LBLG | San Juan District Office (SJN-DO) |
Frequently Asked Questions
What is Lab Delon Y/O Iris B/S's FDA import refusal history?
Lab Delon Y/O Iris B/S (FEI: 3008714618) has 8 FDA import refusal record(s) in our database, spanning from 7/6/2012 to 7/6/2012.
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. Lab Delon Y/O Iris B/S's FEI number is 3008714618.
What types of violations has Lab Delon Y/O Iris B/S received?
Lab Delon Y/O Iris B/S 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 Lab Delon Y/O Iris B/S come from?
All FDA import refusal data for Lab Delon Y/O Iris B/S 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.