Southern Skies
⚠️ Moderate Risk
FEI: 3003508109 • Lachine, 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
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).
AGRINSULIN
The article appears to be composed wholly or partly of insulin manufactured in the US and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for a medical emergency
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/20/2001 | 61PCA99ANTI-DIABETIC N.E.C. | 2060AGRINSULIN | Atlanta District Office (ATL-DO) |
| 12/20/2001 | 61NCA05BUPROPION HCL (ANTI-DEPRESSANT) | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 12/20/2001 | 60LCA83CELECOXIB (ANALGESIC) | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 12/20/2001 | 61NCA78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 12/20/2001 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 12/20/2001 | 62TCA02LANSOPRAZOLE (ANTI-SECRETORY) | 118NOT LISTED | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Southern Skies's FDA import refusal history?
Southern Skies (FEI: 3003508109) has 6 FDA import refusal record(s) in our database, spanning from 12/20/2001 to 12/20/2001.
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. Southern Skies's FEI number is 3003508109.
What types of violations has Southern Skies received?
Southern Skies 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 Southern Skies come from?
All FDA import refusal data for Southern Skies 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.