Decalcorama Inc
✅ Low Risk
FEI: 3009950174 • Saint-Hyacinthe, Quebec • CANADA
FEI Number
3009950174
Location
Saint-Hyacinthe, Quebec
Country
CANADAAddress
5305 Trudeau Ave, , Saint-Hyacinthe, Quebec, 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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
Frequently Asked Questions
What is Decalcorama Inc's FDA import refusal history?
Decalcorama Inc (FEI: 3009950174) has 1 FDA import refusal record(s) in our database, spanning from 11/18/2016 to 11/18/2016.
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. Decalcorama Inc's FEI number is 3009950174.
What types of violations has Decalcorama Inc received?
Decalcorama Inc has been cited for 2 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 Decalcorama Inc come from?
All FDA import refusal data for Decalcorama 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.