Fludan Fine Chemicals Inc
⚠️ Moderate Risk
FEI: 3003446831 • Vankleek Hill, ON • CANADA
FEI Number
3003446831
Location
Vankleek Hill, ON
Country
CANADAAddress
570 Concession 4, , Vankleek 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).
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.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/30/2011 | 62LBL47IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | New York District Office (NYK-DO) | |
| 9/21/2011 | 62LLL47IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | New York District Office (NYK-DO) | |
| 8/30/2002 | 64HAS02GUAIFENESIN (EXPECTORANT) | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/14/2001 | 56ECY22DOXYCYCLINE HYCLATE (TETRACYCLINES) | Detroit District Office (DET-DO) | |
| 11/14/2001 | 54ADP16VITAMIN E (TOCOPHEROL) | 118NOT LISTED | Detroit District Office (DET-DO) |
| 11/14/2001 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | 118NOT LISTED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Fludan Fine Chemicals Inc's FDA import refusal history?
Fludan Fine Chemicals Inc (FEI: 3003446831) has 6 FDA import refusal record(s) in our database, spanning from 11/14/2001 to 11/30/2011.
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. Fludan Fine Chemicals Inc's FEI number is 3003446831.
What types of violations has Fludan Fine Chemicals Inc received?
Fludan Fine Chemicals 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 Fludan Fine Chemicals Inc come from?
All FDA import refusal data for Fludan Fine Chemicals 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.