Eli Lilly issues response to Form 483 at Indianapolis plant
After an Aug. 12 dated Form 483 called out Eli Lilly’s Indianapolis sterile injectables plant for several lapses in quality, the company has issued a 95-page response.
Seven key observations came out of the inspection from the FDA, which took place between February and March of this year. Among them was the lackluster environmental monitoring control in aseptic processing areas, as well as a failure to address employee fatigue. One employee worked for 14 hours on a filling line, which could lead to manual error on the filling line.
In response to the fatigue assessment, the company said it will check operators for fatigue whenever taking a requalification test for manual inspection, including semi-automatic equipment.
“To further ensure consistent challenge of operator fatigue on an ongoing basis, Lilly IPM commits to include additional operator fatigue assessment as part of the requalification program per change control TR40227754, and will requalify operators earlier than their next planned qualification test,” the response stated.
The site makes several medications: bamlanivimab and etesevimab for COVID-19, glucagon for treating severe hypoglycemia in patients with diabetes and ramucirumab for NSC Lung Cancer.
The Form 483 was reported by Reuters in May. That same story said that Lilly employees in Branchburg, NJ accused quality control executives of altering FDA documents to downplay the seriousness of charges. That plant saw a human resources officer forced out of her job after raising concerns surrounding staff shortages and record keeping.
“We take the observations very seriously,” the company stated at the start of its response. “As detailed in our response, we have implemented or are implementing actions to resolve any concerns regarding this inspection on aggressive timelines. We thank the investigators for the discussions we had during the course of the inspection as the feedback contributes to enhancing our operational excellence.”
Eli Lilly had rejected vials from vendors dubbed high risk, yet failed to investigate that for further assessment. As a part of the company’s response, it conducted a characterization assessment based on historical data, the company said, and documented the results in a report. To ensure that the defects remain consistent with the inspection process, Eli Lilly says it has enacted a data collection process for each defect discovered, and a routine review of historical data will be conducted to keep information up-t0-date.
The FDA also found that the written stability program for drug products didn’t include reliable, meaningful and specific test methods. To fix that, Lilly supplied the FDA with the appropriate data, which was redacted in its publication.