Izeen Pharma, Inc. - July 3, 2018
Issue Date
Jul 03, 2018
Region
Central
Category
Drug
$117.00
Contact Name
Mayur G. Phadke
Contact Title
Senior Director Operations
Address 1
6900 English Muffin Way
Address 2
Ste. A
City
Frederick
State
MD
Zip/Postal Code
21703-7157
Country
United States
Inspection Range
Jun 04, 2018 - Jul 03, 2018
Pages
21
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): Jonathan Chapman and David A. Oluwo