Company
United StatesPatheon Biologics (NJ) LLC, Princeton, NJ – FDA Inspections
Inspection records and compliance data for Patheon Biologics (NJ) LLC in Princeton, New Jersey. 5 FDA inspections on record, 1 Form 483, last inspected April 09, 2018.
Company Profile
This profile covers Patheon Biologics (NJ) LLC based in Princeton, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected March 23, 2010. Last inspected April 9, 2018.
Most cited issue areas
- Procedures not in writing, fully followed1 inspection
- Written procedures not established/followed1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 9, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1049824 |
| February 13, 2015 | NAI | Human Drugs · Drug Quality Assurance | 914519 |
| September 26, 2013 | VAI | Human Drugs · Drug Quality Assurance | 850035 |
| September 13, 2011 | NAI | Human Drugs · Drug Quality Assurance | 744300 |
| March 23, 2010 | NAI | Human Drugs · Drug Quality Assurance | 653045 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Patheon Biologics (NJ) LLC
FEI Number
3003976111
Address
201 College Rd E, Princeton, New Jersey 08540, United States
Country
United States
ID: 5d009aee-a952-4eee-a975-1b2bd0559e04