Niagara Pharmaceuticals Inc
⚠️ Moderate Risk
FEI: 3003093882 • Dundas, Ontario • CANADA
FEI Number
3003093882
Location
Dundas, Ontario
Country
CANADAAddress
60 Innovation Dr, , Dundas, 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
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.
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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/8/2011 | 79LRRKIT, FIRST AID | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 11/1/2010 | 55RP70BORIC ACID (PHARMACEUTIC NECESSITY) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/13/2008 | 64WBL99IRRIGATION SOLUTION N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 6/18/2007 | 64WAK99IRRIGATION SOLUTION N.E.C. | Detroit District Office (DET-DO) | |
| 6/18/2007 | 64WAK99IRRIGATION SOLUTION N.E.C. | Detroit District Office (DET-DO) | |
| 6/18/2007 | 64WAK99IRRIGATION SOLUTION N.E.C. | Detroit District Office (DET-DO) | |
| 6/18/2007 | 64WAK99IRRIGATION SOLUTION N.E.C. | Detroit District Office (DET-DO) | |
| 6/18/2007 | 64WAK99IRRIGATION SOLUTION N.E.C. | Detroit District Office (DET-DO) | |
| 6/18/2007 | 64WAK99IRRIGATION SOLUTION N.E.C. | Detroit District Office (DET-DO) | |
| 6/18/2007 | 55RG70BORIC ACID (PHARMACEUTIC NECESSITY) | Detroit District Office (DET-DO) | |
| 6/18/2007 | 55RG70BORIC ACID (PHARMACEUTIC NECESSITY) | Detroit District Office (DET-DO) | |
| 6/18/2007 | 55RG70BORIC ACID (PHARMACEUTIC NECESSITY) | Detroit District Office (DET-DO) | |
| 6/18/2007 | 64WAK99IRRIGATION SOLUTION N.E.C. | Detroit District Office (DET-DO) | |
| 5/10/2007 | 55RP70BORIC ACID (PHARMACEUTIC NECESSITY) | New York District Office (NYK-DO) | |
| 4/9/2007 | 64WAK99IRRIGATION SOLUTION N.E.C. | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Niagara Pharmaceuticals Inc's FDA import refusal history?
Niagara Pharmaceuticals Inc (FEI: 3003093882) has 15 FDA import refusal record(s) in our database, spanning from 4/9/2007 to 2/8/2011.
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. Niagara Pharmaceuticals Inc's FEI number is 3003093882.
What types of violations has Niagara Pharmaceuticals Inc received?
Niagara Pharmaceuticals Inc 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 Niagara Pharmaceuticals Inc come from?
All FDA import refusal data for Niagara Pharmaceuticals 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.