SYMBYX BIOME
⚠️ Moderate Risk
FEI: 3029997768 • Neutral Bay, New South Wales • AUSTRALIA
FEI Number
3029997768
Location
Neutral Bay, New South Wales
Country
AUSTRALIAAddress
L 3 116 Military Rd, , Neutral Bay, New South Wales, Australia
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 REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/23/2024 | 79MVFSYSTEM, LASER, PHOTODYNAMIC THERAPY | 476NO REGISTR | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SYMBYX BIOME's FDA import refusal history?
SYMBYX BIOME (FEI: 3029997768) has 1 FDA import refusal record(s) in our database, spanning from 12/23/2024 to 12/23/2024.
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. SYMBYX BIOME's FEI number is 3029997768.
What types of violations has SYMBYX BIOME received?
SYMBYX BIOME 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 SYMBYX BIOME come from?
All FDA import refusal data for SYMBYX BIOME 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.