Marcus Research Labs, Inc. - March 14, 2011
Issue Date
Mar 14, 2011
Region
Southwest
Category
Drug
$117.00
Address 1
1820 Delmar Blvd.
City
St. Louis
State
MO
Zip/Postal Code
63103
Country
US
Inspection Range
Mar 08, 2010 - Mar 14, 2011
Pages
2
First Observation
You reprocessed batches of "Povidone-Iodine, USP" from 2007 to present, due to suspected specification failures, without first establishing a written protocol and evaluating any possible formations of by-products and over-reacted materials.
Investigator(s): Shafiq S. Ahadi and Sherry G. Bous