MassBiologics - Sept. 1, 2022
Issue Date
Sep 01, 2022
Region
Northeast
Category
Drug
$117.00
Contact Name
Mireli Fino
Contact Title
Executive Vice Chancellor
Address 1
460 Walle Hill St.
City
Boston
State
MA
Zip/Postal Code
02126-3120
Inspection Range
Aug 23, 2022 - Sep 01, 2022
Pages
4
First Observation
Manufacturing procedures designed to prevent microbiological contamination of drug products and media purporting to be sterile during aseptic filling operations are deficient.
Investigator(s): Roger F. Zabinski