Sage Products, LLC
⚠️ Moderate Risk
FEI: 1419181 • Cary, IL • UNITED STATES
FEI Number
1419181
Location
Cary, IL
Country
UNITED STATESAddress
3909 3 Oaks Rd, , Cary, IL, United States
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
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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/25/2024 | 62FDG07CETYLPYRIDINIUM CHLORIDE (ANTI-INFECTIVE, TOPICAL) | 118NOT LISTED | Division of Southwest Imports (DSWI) |
| 4/25/2024 | 62FDG07CETYLPYRIDINIUM CHLORIDE (ANTI-INFECTIVE, TOPICAL) | 118NOT LISTED | Division of Southwest Imports (DSWI) |
| 2/12/2024 | 62FDY08CHLORHEXIDINE HCL (ANTI-INFECTIVE, TOPICAL) | 179AGR RX | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Sage Products, LLC's FDA import refusal history?
Sage Products, LLC (FEI: 1419181) has 3 FDA import refusal record(s) in our database, spanning from 2/12/2024 to 4/25/2024.
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. Sage Products, LLC's FEI number is 1419181.
What types of violations has Sage Products, LLC received?
Sage Products, LLC 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 Sage Products, LLC come from?
All FDA import refusal data for Sage Products, LLC 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.