Cellex International
⚠️ Moderate Risk
FEI: 3001441804 • Toronto, Ontario • CANADA
FEI Number
3001441804
Location
Toronto, Ontario
Country
CANADAAddress
2 Bloor St West Upper Level, , Toronto, 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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/25/2011 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 10/25/2011 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 10/25/2011 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/25/2011 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/25/2011 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/16/2011 | 53PD99OTHER COSMETIC RAW MATERIALS, N.E.C. | 473LABELING | New Orleans District Office (NOL-DO) |
| 9/16/2011 | 53PD99OTHER COSMETIC RAW MATERIALS, N.E.C. | 473LABELING | New Orleans District Office (NOL-DO) |
| 9/16/2011 | 62WBL14ZINC SULFATE ASTRINGENT/ANTI-PERSPIRANT) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 11/12/2002 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Cellex International's FDA import refusal history?
Cellex International (FEI: 3001441804) has 9 FDA import refusal record(s) in our database, spanning from 11/12/2002 to 10/25/2011.
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. Cellex International's FEI number is 3001441804.
What types of violations has Cellex International received?
Cellex International 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 Cellex International come from?
All FDA import refusal data for Cellex International 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.