The plant has been flagged for quality issues after two separate inspections by the FDA, as well as allegations from plant employees that a top quality official altered documents to play down quality issues. Eli Lilly said it is fully cooperating with the investigation of the plant. The FDA inspected the plant in November 2019 and stated that appropriate controls weren't exercised over computers or other related production and laboratory systems. At a second inspection in 2020, the FDA said there had been 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." The agency also said that the plant's laboratory controls didn't include appropriate procedures to make sure its drug products meet appropriate standards of "identity, strength, quality and purity," according to the Journal. After both inspections, Eli Lilly told the FDA it would take corrective actions.