SONY MUSIC ENTERTA
⚠️ Moderate Risk
FEI: 3021219590 • Toronto, ON • CANADA
FEI Number
3021219590
Location
Toronto, ON
Country
CANADAAddress
99 Atlantic Ave, , Toronto, 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/24/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 237NO PMA | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SONY MUSIC ENTERTA's FDA import refusal history?
SONY MUSIC ENTERTA (FEI: 3021219590) has 1 FDA import refusal record(s) in our database, spanning from 5/24/2022 to 5/24/2022.
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. SONY MUSIC ENTERTA's FEI number is 3021219590.
What types of violations has SONY MUSIC ENTERTA received?
SONY MUSIC ENTERTA 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 SONY MUSIC ENTERTA come from?
All FDA import refusal data for SONY MUSIC ENTERTA 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.