Eli Lilly responds to issues raised by FDA inspection, employee complaint

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INDIANAPOLIS – Indianapolis-based Eli Lilly & Co. is responding to reports of quality control problems in at least two of their facilities, including Indianapolis.

One issue involves an FDA inspection at an Indianapolis facility that bottles the Covid-19 antibody treatment drug bamlanivimab.

“I can also confirm that the FDA conducted a general surveillance inspection of Lilly’s manufacturing facility in Indianapolis, and we have submitted our response to their observations,” said Eli Lilly Vice President of Global Communications, Kathryn Beiser.  “Importantly, none of the issues raised in the FDA’s observations affected any finished product or product in the marketplace that was manufactured in this facility.”

While company officials are not commenting on the observations made by the FDA during the March inspection, Reuters News Agency reported that inspectors found substandard sanitation and quality control procedures.

“While the FDA cannot comment on any particular company or any ongoing compliance-related matters, the agency takes the safety and quality of FDA-regulated products seriously,” FDA spokesperson Jeremy Kahn said in an email statement.  “The agency works to ensure that industry complies with numerous measures aimed at protecting the public health and we will always work to resolve any issues in a timely manner.”

The company is also addressing an anonymous employee complaint that alleges an apparent effort to cover up quality control issues at an Eli Lilly facility in New Jersey.  Reuters reported the complaint claimed a top official at the plant altered documents in an effort to downplay quality control issues at the New Jersey facility.

While Beiser did not go into details about the complaint, she said it was being addressed.

“I can confirm that we received an anonymous complaint submitted through our system in April and Lilly had already hired an external party to investigate the allegations in that complaint, and this investigation is still ongoing,” Beiser said.  “Depending on the outcome of that investigation, we will take appropriate action.”

“We take all reports of improper or inappropriate conduct seriously, and we conduct thorough investigations to determine the facts,” Beiser continued.

In March, Reuters reported that a human resources officer at the New Jersey facility claimed she was forced out of her job after raising quality control concerns.  

“Lilly has longstanding policies and procedures designed to enable and even encourage individuals to come forward with information about any potential issues or concerns without fear of retribution,” Beiser stated.

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