483sOnline Subscribe

Search By Date Issued

Search By Category

Drug
Device
Clinical

Search By Company/

Clinical Investigator

Search By Region

Search By FDA Investigator

Search By Keyword

Log in to start searching through our library of thousands of 483s, or Subscribe Now to 483sOnline.com to uncover exactly what FDA Inspectors are thinking about. It’s your own personal pre-investigation intelligence tool that identifies exactly what investigators are focusing on so you can be prepared – before they show up.

Ipsen Bioscience, Inc. - Feb. 26, 2019

Issue Date

Feb 26, 2019

Region

Northeast

Category

Drug
$117.00

Ipsen Bioscience, Inc.

Contact Name

John F. Engelhart

Contact Title

Head of Quality

Form483 Address 1

1 Kendall Sq., Bldg. 700

Form483 Address 2

Ste. 7401

Form483 City

Cambridge

Form483 State

MA

Form483 Postal

02139-1562

Form483 Country

United States

Inspection Range

Feb 11, 2019 - Feb 26, 2019

Pages

3

First Observation

The firm failed to file a NDA-Field Alert Report.
Investigator(s): Robert J. Martin