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.

Robinson Pharma, Inc. - Sept. 25, 2014

Issue Date

Sep 25, 2014

Region

Pacific

Category

Drug
$117.00

Robinson Pharma, Inc.

Contact Name

Fred F. Jamee

Contact Title

Vice President and Chief Quality Officer

Form483 Address 1

3330 S. Harbor Blvd.

Form483 Address 2

Form483 City

Santa Ana

Form483 State

CA

Form483 Postal

92704-6831

Form483 Country

United States

Inspection Range

Sep 12, 2014 - Sep 25, 2014

Pages

7

First Observation

Your quality control operations did not include determining whether each finished batch conforms to established product specifications.
Investigator(s): Trushani T. Desai