483sOnline Subscribe

Search By Date Issued

Search By Category

Drug
Device

Search By Company

Search By Region

Search By 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.

Burke, Inc. - June 8, 2017

Issue Date

Jun 08, 2017

Region

Southwest

Category

Device
$117.00

Burke, Inc.

Contact Name

DuWayne E. Kramer Jr.

Contact Title

President

Form483 Address 1

1800 Merriam Ln.

Form483 Address 2

Form483 City

Kansas City

Form483 State

KS

Form483 Postal

66106-4714

Form483 Country

United States

Inspection Range

Jun 05, 2017 - Jun 08, 2017

Pages

3

First Observation

Procedures for design change have not been adequately established.
Investigator(s): Eric C. Fox