AMO (Hangzhou) Co., Ltd. - July 2, 2019
Issue Date
Jul 02, 2019
Region
HQ
Category
Drug
$117.00
Contact Name
Jack Zhang
Contact Title
Plant Director
Address 1
200 4th Ave.
City
Hangzhou
State
Zhejiang
Zip/Postal Code
310018
Country
China
Inspection Range
Jun 24, 2019 - Jul 02, 2019
Pages
2
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): Joel D. Hustedt