Spartan Chemical Co., Inc. - Dec. 12, 2022
Issue Date
Dec 12, 2022
Region
Central
Category
Drug
$117.00
Contact Name
William J. Schalitz
Contact Title
Vice President, Research and Development
Address 1
1110 Spartan Dr.
City
Maumee
State
OH
Zip/Postal Code
43537-1725
Inspection Range
Dec 05, 2022 - Dec 12, 2022
Pages
5
First Observation
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Investigator(s): Brent M. Dehaan and Jacob G. Lutz