Lubrizol Life Science Health dba Particles Sciences, Inc. - June 24, 2021
Issue Date
Jun 24, 2021
Region
Central
Category
Drug
$117.00
Contact Name
Judith H. Cohen
Contact Title
VP Quality and Regulatory
Address 1
3894 Courtney St.
City
Bethlehem
State
PA
Zip/Postal Code
18017-8920
Country
United States
Inspection Range
Jun 21, 2021 - Jun 24, 2021
Pages
4
First Observation
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
Investigator(s): Viviana Matta