483s in the News
THE BASICS This is resulting from an inspection of the facility on South Delaware Street, Indianapolis, FEI #1819470, which began on September 11, 2023. FDA personnel spent five (5) days on-site. The 483 document is available for purchase/download here. The 483 contains five observations, ranging from failure to ensure prescribing HCPs...
THE BASICS This is resulting from an inspection of the facility at One Moderna Way, Norwood, MA, FEI #3014937058, which began on September 11, 2023. FDA personnel spent nine (9) days on-site. The 483 document is available for purchase/download here. The 483 contains five observations, ranging from failure to properly...
Good to learn