Tuesday, August 17, 2021 Daily Archives

Lilly hit by FDA 483 with 7 observations at IN plant

An Eli Lilly aseptic facility in Indianapolis, which fills COVID-19 antibodies along with other drugs, has received a US FDA Form 483 with seven observations. The Form 483 (available below) was published last week and highlights the issues the US Food and Drug Administration (FDA) found after inspecting the facility in Indianapolis, Indiana in February and March this year. Among the seven observations noted, the Agency highlighted failures by Lilly to establish an adequate system for monitoring environmental conditions in…