Peer Pharm Ltd. - Sept. 11, 2019
Issue Date
Sep 11, 2019
Region
HQ
Category
Drug
$117.00
Contact Name
Haviv Peer
Contact Title
Owner/CEO/General Director
Address 1
17, Amal
City
Rosh Ha-Ayin
Zip/Postal Code
4809256
Country
Israel
Inspection Range
Sep 08, 2019 - Sep 11, 2019
Pages
4
First Observation
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Investigator(s): Michael E. Maselli and Rachael A. Moliver