Company
United StatesPatheon Puerto Rico Inc., Caguas, PR – FDA Inspections
Inspection records and compliance data for Patheon Puerto Rico Inc. in Caguas, Puerto Rico. 3 FDA inspections on record, last inspected March 28, 2013.
Company Profile
This profile covers Patheon Puerto Rico Inc. based in Caguas, Puerto Rico, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected April 8, 2009. Last inspected March 28, 2013.
Most cited issue areas
- Control procedures to monitor and validate performance2 inspections
- Procedures not in writing, fully followed2 inspections
- Complaint Handling Procedure1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 28, 2013 | VAI | Human Drugs · Drug Quality Assurance | 825067 |
| May 4, 2010 | VAI | Human Drugs · Drug Quality Assurance | 663080 |
| April 8, 2009 | VAI | Human Drugs · Drug Quality Assurance | 574468 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Patheon Puerto Rico Inc.
FEI Number
2650178
Address
St. Rd. #1, Km. 34.7, Jose Garrido Ave., Caguas, Puerto Rico 00725, United States
Country
United States
ID: b0f5bb39-71bd-4658-bb17-e8030ca630a3