Nitto Avecia Pharma Services, Inc. - May 24, 2019
Issue Date
May 24, 2019
Region
Pacific
Category
Drug
$117.00
Contact Name
Raymond P. Kaczmarek
Contact Title
President
Address 1
10 Vanderbilt
City
Irvine
State
CA
Zip/Postal Code
92618-2010
Country
United States
Inspection Range
May 20, 2019 - May 24, 2019
Pages
6
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): Eileen A. Liu, Anita Narula, and Joey V. Quitania