Bentley Laboratories, LLC - Aug. 17, 2022
Issue Date
Aug 17, 2022
Region
Central
Category
Drug
$117.00
Contact Name
Gregory C. Torchiana
Contact Title
Chief Executive Officer
Address 1
111 Fieldcrest Ave.
City
Edison
State
NJ
Zip/Postal Code
08837-3622
Inspection Range
Aug 08, 2022 - Aug 17, 2022
Pages
5
First Observation
Control procedures are not established which monitor the output and validate the perfonnance of those manufacturing processes that may be responsible for causing variability in the characteristics of inprocess material and the drug product.
Investigator(s): Monika Borkowska and Anthony Donato