Dexcel Pharma, Ltd. - July 24, 2019
Issue Date
Jul 24, 2019
Region
HQ
Category
Drug
$117.00
Contact Name
Uri Oren
Contact Title
COO
Address 1
Southern Industrial Zone, 1 Dexcel St.
City
Or Akiva
Zip/Postal Code
3060000
Country
Israel
Inspection Range
Jul 21, 2019 - Jul 24, 2019
Pages
6
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): Michael A. Charles and Ivis L. Negron Torres