Company
United StatesJanssen Ortho LLC, Gurabo, PR – FDA Inspections
Inspection records and compliance data for Janssen Ortho LLC in Gurabo, Puerto Rico. 7 FDA inspections on record, 4 Form 483s, last inspected June 05, 2026.
Company Profile
This profile covers Janssen Ortho LLC based in Gurabo, Puerto Rico, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 6
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 4
- Warning letters
- 0
First inspected June 13, 2011. Last inspected June 5, 2026.
Most cited issue areas
- Investigations of discrepancies, failures3 inspections
- Scientifically sound laboratory controls3 inspections
- Computer control of master formula records2 inspections
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 5, 2026 | Not classified | Human Drugs · Drug Quality Assurance | 1320870 |
| March 28, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1200973 |
| August 28, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1063744 |
| May 26, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1012089 |
| May 29, 2015 | VAI | Human Drugs · Drug Quality Assurance | 930456 |
| February 22, 2013 | VAI | Human Drugs · Bioresearch Monitoring | 819622 |
| June 13, 2011 | VAI | Human Drugs · Drug Quality Assurance | 729698 |
FDA documents
People (4)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Janssen Ortho LLC
FEI Number
3002942061
Address
State Road 933 Km 0.1,Mamey Ward, Gurabo, Puerto Rico 00778, United States
Country
United States
ID: d7bbb024-09b4-42ae-bbc5-fad0986f12c6