After FDA Flag, DOJ Looks into Eli Lilly COVID-19 Treatment Manufacturing
Posted on 05/28/2021
The U.S. Department of Justice (DOJ) issued a subpoena to the Branchburg, New Jersey production plant that is responsible for making Eli Lilly’s COVID-19 treatment. The subpoena requests certain documents relating to the manufacturing site in Branchburg. U.S. Food and Drug Administration (FDA) inspectors flagged the plant for quality and data control issues there and at another plant in Indianapolis. Employees at the Branchburg site reportedly accused a factory executive of altering documents. The Branchburg plant manufactures the diabetes drug Trulicity and its COVID-19 antibody drug bamlanivimab.
In a report on a subsequent inspection in 2020, the FDA noted a “failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.” The agency also noted that the plant’s laboratory controls “do not include the establishment of scientifically sound and appropriate lest procedures designed to assure that drug substances conform to appropriate standards of identity, strength, quality and purity.”
Keywords: Eli Lilly & Co.
