Swati Spentose Private Ltd. - Dec. 12, 2018
Issue Date
Dec 12, 2018
Region
HQ
Category
Drug
$117.00
Contact Name
Vishal Jajodia
Contact Title
Chairman and Managing Director
Address 1
Plot No. A-1/2102, 2103, PhaseIII GIDC
City
Vapi
State
Gujarat
Zip/Postal Code
396195
Country
India
Inspection Range
Dec 06, 2018 - Dec 12, 2018
Pages
19
First Observation
Quality Unit lacks oversight on critical activities of API manufacturing, testing, investigations and timely review of controlled documents.
Investigator(s): Christopher S. Keating and Pratik S. Upadhyay