Jacobi Cosmetic Manufacturing Inc
✅ Low Risk
FEI: 3008520879 • Mississauga, ONTARIO • CANADA
FEI Number
3008520879
Location
Mississauga, ONTARIO
Country
CANADAAddress
6504-4 Kestel Road, , Mississauga, ONTARIO, Canada
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
Frequently Asked Questions
What is Jacobi Cosmetic Manufacturing Inc's FDA import refusal history?
Jacobi Cosmetic Manufacturing Inc (FEI: 3008520879) has 1 FDA import refusal record(s) in our database, spanning from 11/18/2010 to 11/18/2010.
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. Jacobi Cosmetic Manufacturing Inc's FEI number is 3008520879.
What types of violations has Jacobi Cosmetic Manufacturing Inc received?
Jacobi Cosmetic Manufacturing 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 Jacobi Cosmetic Manufacturing Inc come from?
All FDA import refusal data for Jacobi Cosmetic Manufacturing 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.