Health 2000 Inc
⚠️ Moderate Risk
FEI: 3007036455 • Richmond Hill, Ontario • CANADA
FEI Number
3007036455
Location
Richmond Hill, Ontario
Country
CANADAAddress
Health 2000 Inc, , Richmond Hill, 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
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/8/2018 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/22/2016 | 61PCB26METFORMIN (ANTI-DIABETIC) | Florida District Office (FLA-DO) | |
| 10/25/2010 | 60XAL28TIMOLOL HEMIHYDRATE (ANTI-ADRENERGIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/25/2010 | 62OBB29ENALAPRILATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Health 2000 Inc's FDA import refusal history?
Health 2000 Inc (FEI: 3007036455) has 4 FDA import refusal record(s) in our database, spanning from 10/25/2010 to 2/8/2018.
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. Health 2000 Inc's FEI number is 3007036455.
What types of violations has Health 2000 Inc received?
Health 2000 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 Health 2000 Inc come from?
All FDA import refusal data for Health 2000 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.