Smart Health Inc. (dba) SmartPractice
✅ Low Risk
FEI: 2083595 • Phoenix, AZ • UNITED STATES
FEI Number
2083595
Location
Phoenix, AZ
Country
UNITED STATESAddress
3400 E McDowell Rd, , Phoenix, AZ, United States
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
Refusal History
Frequently Asked Questions
What is Smart Health Inc. (dba) SmartPractice's FDA import refusal history?
Smart Health Inc. (dba) SmartPractice (FEI: 2083595) has 1 FDA import refusal record(s) in our database, spanning from 9/20/2013 to 9/20/2013.
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. Smart Health Inc. (dba) SmartPractice's FEI number is 2083595.
What types of violations has Smart Health Inc. (dba) SmartPractice received?
Smart Health Inc. (dba) SmartPractice 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 Smart Health Inc. (dba) SmartPractice come from?
All FDA import refusal data for Smart Health Inc. (dba) SmartPractice 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.