Anchen Pharmaceuticals, Inc. - March 3, 2017
Issue Date
Mar 03, 2017
Region
Pacific
Category
Drug
$117.00
Contact Name
Phillip J. Brancazio
Contact Title
GM & Senior Vice President Commercial Operations
Address 1
9601 Jeronimo Rd.
City
Irvine
State
CA
Zip/Postal Code
92618-2025
Country
United States
Inspection Range
Feb 21, 2017 - Mar 03, 2017
Pages
3
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): Liming Zhang