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.

Hamamatsu/Queens PET Imaging Center, LLC - Dec. 13, 2018

Issue Date

Dec 13, 2018

Region

Pacific

Category

Drug
$117.00

Hamamatsu/Queens PET Imaging Center, LLC

Contact Name

Darlena D. Chadwick

Contact Title

Vice President Patient Care

Form483 Address 1

1301 Punchbowl St.

Form483 Address 2

Form483 City

Honolulu

Form483 State

HI

Form483 Postal

96813-2402

Form483 Country

United States

Inspection Range

Dec 11, 2018 - Dec 13, 2018

Pages

4

First Observation

Your firm lacks adequate production and process controls to ensure the consistent production of a PET drug that meets the applicable standards of identity, strength, quality and purity.
Investigator(s): Zachary A. Bogorad, Kenneth O. Gee, Nicholas L. Hunt