Apothecon Pharmaceuticals Private Ltd. - Aug. 24, 2018
Issue Date
Aug 24, 2018
Region
HQ
Category
Drug
$117.00
Contact Name
Raja Jeyakumar
Contact Title
AVP & Executive Director
Address 1
Plot s 1134 -1138 A & B, 1143-B, 1144 A/B, Padra Jambusar Hwy, Tal . Padra, PO Dabhasa
City
Vadodara
State
Gujarat
Zip/Postal Code
391440
Country
India
Inspection Range
Aug 20, 2018 - Aug 24, 2018
Pages
5
First Observation
Drug product production and control records are not reviewed by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
Investigator(s): Roger F. Zabinski