Company
United StatesGlenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ – FDA Inspections
Inspection records and compliance data for Glenmark Pharmaceuticals Inc., USA in Elmwood Park, New Jersey. 3 FDA inspections on record, last inspected December 05, 2016.
Company Profile
This profile covers Glenmark Pharmaceuticals Inc., USA based in Elmwood Park, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected June 29, 2010. Last inspected December 5, 2016.
Most cited issue areas
- Complaint Handling Procedure1 inspection
- Failure to develop written procedures1 inspection
- Late submission of quarterly safety reports1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 5, 2016 | NAI | Human Drugs · Bioresearch Monitoring | 996030 |
| September 9, 2011 | NAI | Human Drugs · Drug Quality Assurance | 743660 |
| June 29, 2010 | VAI | Human Drugs · Bioresearch Monitoring | 669685 |
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
Glenmark Pharmaceuticals Inc., USA
FEI Number
3005658103
Address
619 River Dr, Elmwood Park, New Jersey 07407-1317, United States
Country
United States
ID: a6863099-84a2-4d3f-b3e7-ed7c8ef8abf9