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.

Continental Manufacturing Chemist - July 30, 2019

Issue Date

Jul 30, 2019

Region

Southwest

Category

Drug
$117.00

Continental Manufacturing Chemist

Contact Name

Micheal K. Essmann

Contact Title

Sr. Quality Assurance Specialist

Form483 Address 1

1501 Blue Sky Blvd.

Form483 Address 2

Form483 City

Huxley

Form483 State

IA

Form483 Postal

50124

Form483 Country

United States

Inspection Range

Jul 22, 2019 - Jul 30, 2019

Pages

6

First Observation

The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Investigator(s): Eric T. Huebler, Doan T. Nguyen