Regi International
⚠️ Moderate Risk
FEI: 3004634496 • Crema • ITALY
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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/24/2012 | 53CY06MASCARA (EYE MAKEUP PREPARATIONS) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/29/2012 | 53CY06MASCARA (EYE MAKEUP PREPARATIONS) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/26/2012 | 53CY06MASCARA (EYE MAKEUP PREPARATIONS) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/16/2012 | 53CY06MASCARA (EYE MAKEUP PREPARATIONS) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/6/2011 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Regi International's FDA import refusal history?
Regi International (FEI: 3004634496) has 5 FDA import refusal record(s) in our database, spanning from 6/6/2011 to 10/24/2012.
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. Regi International's FEI number is 3004634496.
What types of violations has Regi International received?
Regi International has been cited for 4 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 Regi International come from?
All FDA import refusal data for Regi International 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.