Company
United StatesSandoz Incorporated, East Hanover, NJ – FDA Inspections
Inspection records and compliance data for Sandoz Incorporated in East Hanover, New Jersey. 8 FDA inspections on record (1 OAI), 1 Form 483, last inspected April 16, 2019.
Company Profile
This profile covers Sandoz Incorporated based in East Hanover, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 1
- VAI
- 6
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected October 8, 2008. Last inspected April 16, 2019.
Most cited issue areas
- Late submission of 15-day report3 inspections
- Cleaning / Sanitizing / Maintenance2 inspections
- Authority lacking to review records, investigate errors1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 16, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1087173 |
| March 29, 2017 | NAI | Human Drugs · Drug Quality Assurance | 1013036 |
| October 30, 2015 | VAI | Human Drugs · Drug Quality Assurance | 981954 |
| October 17, 2013 | VAI | Human Drugs · Postmarket Surv. and Epidemiology | 853190 |
| August 14, 2012 | VAI | Human Drugs · Drug Quality Assurance | 797878 |
| May 6, 2011 | OAI | Human Drugs · Drug Quality Assurance | 727431 |
| May 28, 2010 | VAI | Human Drugs · Drug Quality Assurance | 669731 |
| October 8, 2008 | VAI | Human Drugs · Bioresearch Monitoring | 541807 |
FDA documents
Form 483s (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Sandoz Incorporated
FEI Number
1717759
Address
1 Health Plz, East Hanover, New Jersey 07936, United States
Country
United States
ID: 6aa8ae0e-b0f0-49a7-a584-c6e6796c6481