Asept Pak, Inc. - Dec. 20, 2019
Issue Date
Dec 20, 2019
Region
Northeast
Category
Drug
$117.00
Contact Name
Gary L. Hanley
Contact Title
President and Chief Executive Officer
Address 1
64 West St.
City
Malone
State
NY
Zip/Postal Code
12953-1118
Country
United States
Inspection Range
Dec 11, 2019 - Dec 20, 2019
Pages
7
First Observation
Control procedures are not established which monitor the output and 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): Rajiv R. Srivastava