CHASE PHARMA A DIV OF STELLA PHARMACEUTICAL CANADA IN
⚠️ Moderate Risk
FEI: 3003002220 • North York, Ontario • CANADA
FEI Number
3003002220
Location
North York, Ontario
Country
CANADAAddress
220 Duncan Mill Rd, , North York, 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
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).
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.
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.
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).
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/2/2016 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Northeast Imports (DNEI) | |
| 4/27/2016 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Northeast Imports (DNEI) | |
| 4/24/2009 | 54ACC90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 218LIST INGRE | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is CHASE PHARMA A DIV OF STELLA PHARMACEUTICAL CANADA IN's FDA import refusal history?
CHASE PHARMA A DIV OF STELLA PHARMACEUTICAL CANADA IN (FEI: 3003002220) has 3 FDA import refusal record(s) in our database, spanning from 4/24/2009 to 5/2/2016.
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. CHASE PHARMA A DIV OF STELLA PHARMACEUTICAL CANADA IN's FEI number is 3003002220.
What types of violations has CHASE PHARMA A DIV OF STELLA PHARMACEUTICAL CANADA IN received?
CHASE PHARMA A DIV OF STELLA PHARMACEUTICAL CANADA IN has been cited for 5 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 CHASE PHARMA A DIV OF STELLA PHARMACEUTICAL CANADA IN come from?
All FDA import refusal data for CHASE PHARMA A DIV OF STELLA PHARMACEUTICAL CANADA IN 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.