Marcus Research Laboratory, Inc. - June 20, 2014
Issue Date
Jun 20, 2014
Region
Central
Category
Device
$117.00
Contact Name
Richard A. Gilbert
Contact Title
Vice President & Production Manager
Address 1
1820 Delmar Blvd.
City
St. Louis
State
MO
Zip/Postal Code
63103
Country
United States
Inspection Range
Jun 16, 2014 - Jun 20, 2014
Pages
4
First Observation
You do not monitor and record temperature or humidity in the room where Non-Cl Povidone undergoes its moisturization phase to be used in the manufacture of "Povidone-Iodine, USP" when it has been determined that this phase is a critical step in the manufacturing process and will affect your final product.
Investigator(s): Monica M. McClure