Roquette America, Inc. - June 17, 2021
Issue Date
Jun 17, 2021
Region
Southwest
Category
Drug
$117.00
Contact Name
Thomas A. Crenshaw
Contact Title
Quality Assurance Manager
Address 1
1003 S. 5th St.
City
Keokuk
State
IA
Zip/Postal Code
52632
Country
United States
Inspection Range
Jun 14, 2021 - Jun 17, 2021
Pages
2
First Observation
From November 2018 until November 2019 you did not perform resolution or system suitability for HPLC assay which includes impurity assay on your finished product testing of Dextrose Monohydrate API according to your method.
Investigator(s): Carl A. Huffman III and Jill J. Tillman