WOMEN'S AND CHILD HEALTH RESEARCH I
⚠️ Moderate Risk
FEI: 3026333427 • Edmonton, AB • CANADA
FEI Number
3026333427
Location
Edmonton, AB
Country
CANADAAddress
085 11405 87 Ave Room 4, , Edmonton, AB, 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
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)
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
Frequently Asked Questions
What is WOMEN'S AND CHILD HEALTH RESEARCH I's FDA import refusal history?
WOMEN'S AND CHILD HEALTH RESEARCH I (FEI: 3026333427) has 2 FDA import refusal record(s) in our database, spanning from 4/3/2023 to 4/3/2023.
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. WOMEN'S AND CHILD HEALTH RESEARCH I's FEI number is 3026333427.
What types of violations has WOMEN'S AND CHILD HEALTH RESEARCH I received?
WOMEN'S AND CHILD HEALTH RESEARCH I 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 WOMEN'S AND CHILD HEALTH RESEARCH I come from?
All FDA import refusal data for WOMEN'S AND CHILD HEALTH RESEARCH I 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.