Anti Aging Solutions Inc.
⚠️ Moderate Risk
FEI: 3004127431 • Etobicoke, Ontario • CANADA
FEI Number
3004127431
Location
Etobicoke, Ontario
Country
CANADAAddress
5-1 Westside Dr, , Etobicoke, 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
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
INVDEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a device for investigational use for which no exemption has been granted as prescribed by Section 520(g)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/7/2004 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 3081INVDEVICE | New York District Office (NYK-DO) |
| 9/21/2003 | 95L32CD PLAYER COMBINATION SYSTEMS | 237NO PMA | New Orleans District Office (NOL-DO) |
| 6/26/2003 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 237NO PMA | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Anti Aging Solutions Inc.'s FDA import refusal history?
Anti Aging Solutions Inc. (FEI: 3004127431) has 3 FDA import refusal record(s) in our database, spanning from 6/26/2003 to 1/7/2004.
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. Anti Aging Solutions Inc.'s FEI number is 3004127431.
What types of violations has Anti Aging Solutions Inc. received?
Anti Aging Solutions 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 Anti Aging Solutions Inc. come from?
All FDA import refusal data for Anti Aging Solutions 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.