Advance Pharmaceutical, Inc. - Dec. 2, 2015
Issue Date
Dec 02, 2015
Region
Northeast
Category
Drug
$117.00
Contact Name
Tasrin Hossain
Contact Title
President
Address 1
895 Waverly Ave.
City
Holtsville
State
NY
Zip/Postal Code
11742-1109
Country
United States
Inspection Range
Nov 12, 2015 - Dec 02, 2015
Pages
7
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): Charisse K. Green, Jose O. Hernandez-Guzman, and Rachael A. Moliver