American Regent, Inc.
⚠️ Moderate Risk
FEI: 2410375 • Shirley, NY • UNITED STATES
FEI Number
2410375
Location
Shirley, NY
Country
UNITED STATESAddress
5 Ramsay Rd, , Shirley, NY, 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
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.
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).
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.
FORBIDDEN
The article is subject to refusal of admission pursuant to Section 801(a)(2) in that it appears to be forbidden or restricted in sale in the country in which it was produced or from which it was exported.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/22/2023 | 66MDA83HYDROXYZINE HCL (TRANQUILIZER) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 12/19/2012 | 76DZNMATRIX, DENTAL | Division of Southeast Imports (DSEI) | |
| 8/16/2012 | 68YCK02HORSES ANIMAL DRUGS N.E.C. | Division of Northeast Imports (DNEI) | |
| 5/8/2012 | 62CAY10CLONIDINE HCL (ANTI-HYPERTENSIVE) | 179AGR RX | Detroit District Office (DET-DO) |
| 5/27/2008 | 54BGP13ZINC (MINERAL) | 179AGR RX | Cincinnati District Office (CIN-DO) |
| 2/4/2004 | 55RP47SUCROSE (PHARMACEUTIC NECESSITY - TABLET EXCIPIENT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is American Regent, Inc.'s FDA import refusal history?
American Regent, Inc. (FEI: 2410375) has 6 FDA import refusal record(s) in our database, spanning from 2/4/2004 to 3/22/2023.
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. American Regent, Inc.'s FEI number is 2410375.
What types of violations has American Regent, Inc. received?
American Regent, Inc. has been cited for 6 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 American Regent, Inc. come from?
All FDA import refusal data for American Regent, 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.