Par Sterile Products, LLC - July 20, 2021
Issue Date
Jul 20, 2021
Region
Central
Category
Drug
$117.00
Contact Name
Paula Del Papa
Contact Title
Interim General Manager
Address 1
870 Parkdale Rd.
City
Rochester
State
MI
Zip/Postal Code
48307
Country
United States
Inspection Range
Jul 14, 2021 - Jul 20, 2021
Pages
3
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 the drug product.
Investigator(s): Joseph Piechocki and Michael R. Shanks