Justice Department Hits Eli Lilly with Subpoena
Eli Lilly says it has received a subpoena from the U.S. Department of Justice requesting certain documents about its troubled manufacturing site in Branchburg, NJ. Earlier this month, an internal Lilly complaint alleged that a factory executive changed technical documents required by government regulators to downplay serious quality control problems at the facility that makes the company’s bamlanivimab Covid-19 therapy (see earlier story). Reuters reported in an exclusive story that the complaint involved Lydia Wible, an executive at the facility.
Lilly had confirmed receiving an employee complaint about the Branchburg plant and said that it would not comment further due to an investigation underway by an unidentified independent third party. “Depending on the outcome of that investigation, we will take appropriate action,” Lilly spokesperson Kathryn Beiser told the news service at the time. “Lilly has long-standing policies and procedures designed to enable, and encourage, individuals to come forward with information about any potential issues or concerns without fear of retribution.”
Late last year, FDA posted a Form FDA-483 detailing significant quality and laboratory control issues found during an 8/2020 reinspection at the Branchburg facility. The FDA-483 said that there was a quality 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.” For example, FDA said incidents that occurred during GMP activities that may have had an impact on product quality were not investigated. Such incidents were classified as “observations” instead of “deviations” and were closed without documenting all the investigation details, root causes surrounding the issue and implementing corrective actions, the agency said. On the laboratory side, the FDA-483 said lab controls “do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug substances conform to appropriate standards of identity, strength, quality and purity.”
The reinspection followed an 11/2019 inspection and according to an FDA-483 appropriate controls were not being exercised over computers or related production systems at the facility. The agency said that electronic files identified as Calibration Study, Qualification Study and Verification Study had been deleted, adding that the “deleted incidents and related audit trail were not reviewed by the quality unit.” Appropriate controls were also not exercised over computers or related laboratory systems, FDA said, specifically identifying quality control laboratory data stored on multiple stand-alone equipment computer systems that were not secured from modification or deletion.