K Tracey
⚠️ Moderate Risk
FEI: 3008784738 • Little Currentlittle Current, ON • CANADA
FEI Number
3008784738
Location
Little Currentlittle Current, ON
Country
CANADAAddress
13 Mcbane Lanebox 811, , Little Currentlittle Current, 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/11/2011 | 66VCC99MISCELLANEOUS PATENT MEDICINES, ETC. | 27DRUG GMPS | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is K Tracey's FDA import refusal history?
K Tracey (FEI: 3008784738) has 1 FDA import refusal record(s) in our database, spanning from 3/11/2011 to 3/11/2011.
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. K Tracey's FEI number is 3008784738.
What types of violations has K Tracey received?
K Tracey has been cited for 1 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 K Tracey come from?
All FDA import refusal data for K Tracey 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.