Custom HBC Corporation
✅ Low Risk
FEI: 3005304781 • Waconia, MN • UNITED STATES
FEI Number
3005304781
Location
Waconia, MN
Country
UNITED STATESAddress
888 Industrial Blvd, , Waconia, MN, United States
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).
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.
Refusal History
Frequently Asked Questions
What is Custom HBC Corporation's FDA import refusal history?
Custom HBC Corporation (FEI: 3005304781) has 1 FDA import refusal record(s) in our database, spanning from 4/24/2007 to 4/24/2007.
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. Custom HBC Corporation's FEI number is 3005304781.
What types of violations has Custom HBC Corporation received?
Custom HBC Corporation 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 Custom HBC Corporation come from?
All FDA import refusal data for Custom HBC Corporation 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.