Emergent Biosolutions, LLC - Aug. 16, 2023
Issue Date
Aug 16, 2023
Region
Northeast
Category
Drug
$117.00
Contact Name
Kristine Marchant
Contact Title
Vice President & General Manager
Address 1
50/90 Shawmut Rd.
City
Canton
State
MA
Zip/Postal Code
02021-1409
Inspection Range
Aug 07, 2023 - Aug 16, 2023
Pages
3
First Observation
Records associated with investigations into deviations of drug substance manufacturing and within the retention period for such records, were not made readily available for authorized inspection.
Investigator(s): Shafiq S. Ahadi, Lewis K. Antwi, and Unnee Ranjan