Company
United StatesAmarin Pharma Inc., Bedminster, NJ – FDA Inspections
Inspection records and compliance data for Amarin Pharma Inc. in Bedminster, New Jersey. 3 FDA inspections on record, last inspected August 02, 2019.
Company Profile
This profile covers Amarin Pharma Inc. based in Bedminster, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected October 29, 2013. Last inspected August 2, 2019.
Most cited issue areas
- Failure to develop written procedures1 inspection
- Failure to identify post marketing study reports1 inspection
- Failure to review ADE information1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 2, 2019 | NAI | Human Drugs · Bioresearch Monitoring | 1100373 |
| September 9, 2014 | VAI | Human Drugs · Drug Quality Assurance | 891859 |
| October 29, 2013 | NAI | Human Drugs · Bioresearch Monitoring | 854226 |
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
Amarin Pharma Inc.
FEI Number
3010326898
Address
1430 Us Highway 206 Ste 200, Bedminster, New Jersey 07921, United States
Country
United States
ID: dd301a42-2e08-4db9-929f-eaf4891ffad7