Spartan Chemical Co., Inc. - March 26, 2021
Issue Date
Mar 26, 2021
Region
Central
Category
Drug
$117.00
Contact Name
William J. Schalitz
Contact Title
Vice President, R&D
Address 1
1110 Spartan Dr.
City
Maumee
State
OH
Zip/Postal Code
43537-1725
Country
United States
Inspection Range
Mar 01, 2021 - Mar 26, 2021
Pages
7
First Observation
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Investigator(s): Alan M. Barker, Matthew Casale, and Jacob G. Lutz