Canadian College Of Holistic Health
⚠️ Moderate Risk
FEI: 3003746981 • Richmond Hill, ON • CANADA
FEI Number
3003746981
Location
Richmond Hill, ON
Country
CANADAAddress
10670 Yonge, , Richmond Hill, ON, 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
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).
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/3/2011 | 60QAL67LIDOCAINE (ANESTHETIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 6/3/2011 | 60QAL67LIDOCAINE (ANESTHETIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 5/17/2011 | 60QAJ99ANESTHETIC, N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 5/17/2011 | 60QAJ99ANESTHETIC, N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 5/11/2011 | 60QDJ67LIDOCAINE (ANESTHETIC) | New York District Office (NYK-DO) | |
| 3/8/2011 | 60QBJ67LIDOCAINE (ANESTHETIC) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Canadian College Of Holistic Health's FDA import refusal history?
Canadian College Of Holistic Health (FEI: 3003746981) has 6 FDA import refusal record(s) in our database, spanning from 3/8/2011 to 6/3/2011.
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. Canadian College Of Holistic Health's FEI number is 3003746981.
What types of violations has Canadian College Of Holistic Health received?
Canadian College Of Holistic Health has been cited for 4 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 Canadian College Of Holistic Health come from?
All FDA import refusal data for Canadian College Of Holistic Health 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.