Company
United StatesIPR Pharmaceuticals, Inc., Canovanas, PR – FDA Inspections
Inspection records and compliance data for IPR Pharmaceuticals, Inc. in Canovanas, Puerto Rico. 7 FDA inspections on record, 1 Form 483, 2 warning letters, last inspected May 12, 2025.
Company Profile
This profile covers IPR Pharmaceuticals, Inc. based in Canovanas, Puerto Rico, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 4
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 2
First inspected October 8, 2008. Last inspected May 12, 2025.
Most cited issue areas
- Control procedures to monitor and validate performance2 inspections
- Investigations of discrepancies, failures1 inspection
- SOPs not followed / documented1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 12, 2025 | NAI | Human Drugs · Drug Quality Assurance | 1271831 |
| June 14, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1055499 |
| August 26, 2015 | NAI | Human Drugs · Drug Quality Assurance | 942102 |
| July 29, 2013 | VAI | Human Drugs · Drug Quality Assurance | 844409 |
| December 7, 2010 | NAI | Human Drugs · Drug Quality Assurance | 701582 |
| December 21, 2009 | VAI | Human Drugs · Drug Quality Assurance | 635541 |
| October 8, 2008 | VAI | Human Drugs · Drug Quality Assurance | 544384 |
FDA documents
Form 483s (1)
Warning Letters (2)
Other FDA documents (1)
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Company Information
Name
IPR Pharmaceuticals, Inc.
FEI Number
3003009422
Address
Road 188, Lot#17, San Isdro Indus Park Lot, Canovanas, Puerto Rico 00729, United States
Country
United States
ID: b4dde979-22da-4c56-93c5-a44a726cff7a