Gallimore Healthcare Prdts Ltd
⚠️ Moderate Risk
FEI: 1833308 • North York, Ontario • CANADA
FEI Number
1833308
Location
North York, Ontario
Country
CANADAAddress
23a Railside Rd, , 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
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/15/2003 | 79KGOSURGEON'S GLOVES | 477HOLES | New York District Office (NYK-DO) |
| 7/8/2003 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | New York District Office (NYK-DO) |
| 7/8/2003 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | New York District Office (NYK-DO) |
| 6/6/2003 | 79KGOSURGEON'S GLOVES | 477HOLES | New York District Office (NYK-DO) |
| 6/6/2003 | 79KGOSURGEON'S GLOVES | 477HOLES | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Gallimore Healthcare Prdts Ltd's FDA import refusal history?
Gallimore Healthcare Prdts Ltd (FEI: 1833308) has 5 FDA import refusal record(s) in our database, spanning from 6/6/2003 to 7/15/2003.
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. Gallimore Healthcare Prdts Ltd's FEI number is 1833308.
What types of violations has Gallimore Healthcare Prdts Ltd received?
Gallimore Healthcare Prdts Ltd 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 Gallimore Healthcare Prdts Ltd come from?
All FDA import refusal data for Gallimore Healthcare Prdts 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.