Epic Pharma, LLC - Feb. 1, 2019
Issue Date
Feb 01, 2019
Region
Northeast
Category
Drug
$117.00
Contact Name
Christopher Aupperlee
Contact Title
VP, Quality Systems
Address 1
22715 N. Conduit Ave.
City
Laurelton
State
NY
Zip/Postal Code
11413-3134
Country
United States
Inspection Range
Jan 02, 2019 - Feb 01, 2019
Pages
5
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): Alice S. Tsao