Southmedic, Inc.
⚠️ Moderate Risk
FEI: 3001717360 • Barrie, Ontario • CANADA
FEI Number
3001717360
Location
Barrie, Ontario
Country
CANADAAddress
50 Alliance Blvd, , Barrie, 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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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 |
|---|---|---|---|
| 11/27/2009 | 73CATCANNULA, NASAL, OXYGEN | 341REGISTERED | Detroit District Office (DET-DO) |
| 11/27/2009 | 73BYXTUBING, PRESSURE AND ACCESSORIES | 341REGISTERED | Detroit District Office (DET-DO) |
| 11/27/2009 | 73BYGMASK, OXYGEN | 341REGISTERED | Detroit District Office (DET-DO) |
| 11/27/2009 | 73BYXTUBING, PRESSURE AND ACCESSORIES | 341REGISTERED | Detroit District Office (DET-DO) |
| 11/27/2009 | 73BYGMASK, OXYGEN | 341REGISTERED | Detroit District Office (DET-DO) |
| 12/10/2008 | 73CADVAPORIZER, ANESTHESIA, NON-HEATED | 341REGISTERED | Detroit District Office (DET-DO) |
| 2/27/2007 | 73BYGMASK, OXYGEN | Detroit District Office (DET-DO) | |
| 8/1/2006 | 73BYGMASK, OXYGEN | 341REGISTERED | Detroit District Office (DET-DO) |
| 8/1/2006 | 73BYGMASK, OXYGEN | 341REGISTERED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Southmedic, Inc.'s FDA import refusal history?
Southmedic, Inc. (FEI: 3001717360) has 9 FDA import refusal record(s) in our database, spanning from 8/1/2006 to 11/27/2009.
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. Southmedic, Inc.'s FEI number is 3001717360.
What types of violations has Southmedic, Inc. received?
Southmedic, Inc. has been cited for 2 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 Southmedic, Inc. come from?
All FDA import refusal data for Southmedic, 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.