IPR Pharmaceuticals, Inc.
⚠️ High Risk
FEI: 3003009422 • Canovanas, PR • UNITED STATES
FEI Number
3003009422
Location
Canovanas, PR
Country
UNITED STATESAddress
Road 188, Lot 17, San Isidro Industrial Park, Canovanas, PR, United States
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/17/2025 | 61JCA16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/23/2025 | 61JCA16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/22/2025 | 61JDA16ROSUVASTATIN CALCIUM | Division of Southeast Imports (DSEI) | |
| 3/23/2021 | 61JCA16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/4/2017 | 62OAA19CANDESARTAN CILEXETIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/21/2016 | 61JCA16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/30/2016 | 61JCC16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/17/2015 | 61JDB16ROSUVASTATIN CALCIUM | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/28/2014 | 61JCA16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/15/2012 | 61JCA16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/21/2011 | 61JCC16ROSUVASTATIN CALCIUM | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is IPR Pharmaceuticals, Inc.'s FDA import refusal history?
IPR Pharmaceuticals, Inc. (FEI: 3003009422) has 11 FDA import refusal record(s) in our database, spanning from 11/21/2011 to 11/17/2025.
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. IPR Pharmaceuticals, Inc.'s FEI number is 3003009422.
What types of violations has IPR Pharmaceuticals, Inc. received?
IPR Pharmaceuticals, Inc. 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 IPR Pharmaceuticals, Inc. come from?
All FDA import refusal data for IPR Pharmaceuticals, 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.