Sky Service Airline
⚠️ Moderate Risk
FEI: 3003778012 • Mississauga, ON • CANADA
FEI Number
3003778012
Location
Mississauga, ON
Country
CANADAAddress
6120 Midfield Rd, , Mississauga, 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
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/22/2002 | 54ADA12FOLIC ACID (VITAMIN) | 2300DIETARYLBL | New Orleans District Office (NOL-DO) |
| 11/22/2002 | 54ADA05VITAMIN B12 (CYANOCOBALAMIN) | 2300DIETARYLBL | New Orleans District Office (NOL-DO) |
| 11/22/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Sky Service Airline's FDA import refusal history?
Sky Service Airline (FEI: 3003778012) has 3 FDA import refusal record(s) in our database, spanning from 11/22/2002 to 11/22/2002.
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. Sky Service Airline's FEI number is 3003778012.
What types of violations has Sky Service Airline received?
Sky Service Airline 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 Sky Service Airline come from?
All FDA import refusal data for Sky Service Airline 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.