U.S. Pharmaceuticals Group
⚠️ Moderate Risk
FEI: 3001238068 • New York, NY • UNITED STATES
FEI Number
3001238068
Location
New York, NY
Country
UNITED STATESAddress
235 East 42nd Street, , New York, 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
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).
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 |
|---|---|---|---|
| 11/12/2014 | 62OCB14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/18/2012 | 61JIA16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 5/15/2006 | 63XCA99DIAGOSTIC AID (DRUGS) N.E.C. | 179AGR RX | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is U.S. Pharmaceuticals Group's FDA import refusal history?
U.S. Pharmaceuticals Group (FEI: 3001238068) has 3 FDA import refusal record(s) in our database, spanning from 5/15/2006 to 11/12/2014.
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. U.S. Pharmaceuticals Group's FEI number is 3001238068.
What types of violations has U.S. Pharmaceuticals Group received?
U.S. Pharmaceuticals Group 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 U.S. Pharmaceuticals Group come from?
All FDA import refusal data for U.S. Pharmaceuticals Group 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.