Par Sterile Products, LLC - April 14, 2023
Issue Date
Apr 14, 2023
Region
Central
Category
Drug
$117.00
Contact Name
Paula A. Del Papa
Contact Title
Vice President & General Manager Manufacturing Operations
Address 1
870 Parkdale Rd.
City
Rochester
State
MI
Zip/Postal Code
48307-1740
Inspection Range
Apr 05, 2023 - Apr 14, 2023
Pages
4
First Observation
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed
Investigator(s): Joohi Castelvetere, Jacob G. Lutz, and Joseph Piechocki