Indukern Chemie Canada Inc
⚠️ Moderate Risk
FEI: 3002990222 • Brampton, ON • CANADA
FEI Number
3002990222
Location
Brampton, ON
Country
CANADAAddress
18 Automatic Road 27, , Brampton, 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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/3/2002 | 66YIK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | New Orleans District Office (NOL-DO) | |
| 7/3/2002 | 66YIK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/14/2001 | 56GYS50NYSTATIN (ANTIFUNGAL) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 12/14/2001 | 56GYS50NYSTATIN (ANTIFUNGAL) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Indukern Chemie Canada Inc's FDA import refusal history?
Indukern Chemie Canada Inc (FEI: 3002990222) has 4 FDA import refusal record(s) in our database, spanning from 12/14/2001 to 7/3/2002.
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. Indukern Chemie Canada Inc's FEI number is 3002990222.
What types of violations has Indukern Chemie Canada Inc received?
Indukern Chemie Canada Inc 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 Indukern Chemie Canada Inc come from?
All FDA import refusal data for Indukern Chemie Canada Inc 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.