PROTECTOR SAFETY & MEDICAL PRODUCTS
⚠️ Moderate Risk
FEI: 6530 • North York, Ontario • CANADA
FEI Number
6530
Location
North York, Ontario
Country
CANADAAddress
1111 Flint Rd Unit 23, , North York, Ontario, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/23/2009 | 55RY70BORIC ACID (PHARMACEUTIC NECESSITY) | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/23/2009 | 80FLKTHERMOMETER, CLINICAL MERCURY | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/23/2009 | 73NMCMASK, VENTILATOR, NON-CONTINUOUS,REPROCESSED | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/23/2009 | 79FXXMASK, SURGICAL | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/23/2009 | 80FMCGLOVE, PATIENT EXAMINATION | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/23/2009 | 80FMCGLOVE, PATIENT EXAMINATION | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/23/2009 | 79LRRKIT, FIRST AID | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/15/2009 | 79LRRKIT, FIRST AID | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is PROTECTOR SAFETY & MEDICAL PRODUCTS's FDA import refusal history?
PROTECTOR SAFETY & MEDICAL PRODUCTS (FEI: 6530) has 8 FDA import refusal record(s) in our database, spanning from 9/15/2009 to 9/23/2009.
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. PROTECTOR SAFETY & MEDICAL PRODUCTS's FEI number is 6530.
What types of violations has PROTECTOR SAFETY & MEDICAL PRODUCTS received?
PROTECTOR SAFETY & MEDICAL PRODUCTS has been cited for 1 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 PROTECTOR SAFETY & MEDICAL PRODUCTS come from?
All FDA import refusal data for PROTECTOR SAFETY & MEDICAL PRODUCTS 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.