Itsi Inc
⚠️ Moderate Risk
FEI: 3004023285 • Princeton, ON • CANADA
FEI Number
3004023285
Location
Princeton, ON
Country
CANADAAddress
9 Woodbury Lane R, , Princeton, 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
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.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and 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 |
|---|---|---|---|
| 8/27/2009 | 56DXL20GENTAMICIN (AMINOGLYCOSIDES) | Detroit District Office (DET-DO) | |
| 8/27/2009 | 56DXL20GENTAMICIN (AMINOGLYCOSIDES) | Detroit District Office (DET-DO) | |
| 8/27/2009 | 68FBL99OTHER ANIMAL, N.E.C. HORMONES | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Itsi Inc's FDA import refusal history?
Itsi Inc (FEI: 3004023285) has 3 FDA import refusal record(s) in our database, spanning from 8/27/2009 to 8/27/2009.
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. Itsi Inc's FEI number is 3004023285.
What types of violations has Itsi Inc received?
Itsi 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 Itsi Inc come from?
All FDA import refusal data for Itsi 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.