Saptalis Pharmaceuticals, LLC - March 17, 2023
Issue Date
Mar 17, 2023
Region
Northeast
Category
Drug
$117.00
Contact Name
Polireddy Dondeti
Contact Title
President & CEO
Address 1
20 Davids Dr.
City
Hauppauge
State
NY
Zip/Postal Code
11788-2005
Inspection Range
Mar 09, 2023 - Mar 17, 2023
Pages
4
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): Amatul H. Marium, Bijoy Panicker, and Josh Renzo N. Ramilo