Trividia Health, Inc.
⚠️ Moderate Risk
FEI: 1000113657 • Fort Lauderdale, FL • UNITED STATES
FEI Number
1000113657
Location
Fort Lauderdale, FL
Country
UNITED STATESAddress
3230 W Prospect Rd, , Fort Lauderdale, FL, United States
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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 |
|---|---|---|---|
| 3/4/2025 | 61PBG99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/15/2012 | 78NTZSTRIP, DIALYSATE, PH, BICARBONATE, GLUCOSE, ACID, INDICATOR | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/21/2009 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 341REGISTERED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Trividia Health, Inc.'s FDA import refusal history?
Trividia Health, Inc. (FEI: 1000113657) has 3 FDA import refusal record(s) in our database, spanning from 8/21/2009 to 3/4/2025.
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. Trividia Health, Inc.'s FEI number is 1000113657.
What types of violations has Trividia Health, Inc. received?
Trividia Health, Inc. has been cited for 3 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 Trividia Health, Inc. come from?
All FDA import refusal data for Trividia Health, 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.