Medex Cardio-Pulmonary, Inc. d.b.a. Smiths Medical Co. - July 10, 2017
Issue Date
Jul 10, 2017
Region
Central
Category
Device
$117.00
Contact Name
Robert W. Turoff
Contact Title
Director of Operations
Address 1
330 Corporate Woods Pkwy.
City
Vernon Hills
State
IL
Zip/Postal Code
60061-3107
Country
United States
Inspection Range
Jun 20, 2017 - Jul 10, 2017
Pages
13
First Observation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Investigator(s): Christopher D. Leach and Jesse A. Vazquez