Degil Safety Products 1989 Inc
⚠️ Moderate Risk
FEI: 3000142023 • Woodbridge, ON • CANADA
FEI Number
3000142023
Location
Woodbridge, ON
Country
CANADAAddress
200 Zenway Blvd Unit 1, , Woodbridge, ON, 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/7/2010 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 6/19/2007 | 64AAL20TRICLOSAN (DISINFECTANT) | New York District Office (NYK-DO) | |
| 7/8/2003 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Degil Safety Products 1989 Inc's FDA import refusal history?
Degil Safety Products 1989 Inc (FEI: 3000142023) has 3 FDA import refusal record(s) in our database, spanning from 7/8/2003 to 9/7/2010.
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. Degil Safety Products 1989 Inc's FEI number is 3000142023.
What types of violations has Degil Safety Products 1989 Inc received?
Degil Safety Products 1989 Inc 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 Degil Safety Products 1989 Inc come from?
All FDA import refusal data for Degil Safety Products 1989 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.