Report: FDA issued OAI notice to Lilly plant getting ready produce COVID-19 antibody therapy

The New Jersey Eli Lilly plant that is getting prepped to manufacture the company’s antibody treatment for the coronavirus has been cited for quality violations by the FDA. 

According to a report in Reuters, FDA inspectors visited the plant in November and found that manufacturing process data at the plant had been deleted and not audited appropriately. The findings ultimately resulted in an “Official Action Indicated” notice from the FDA — one of the agency’s most serious violations.

Sources also told Reuters that employees at the site had complained that the company was falsifying records — but the FDA found no evidence of falsification.  

Lilly said that it has been working with the FDA and has put a comprehensive remediation plan in place.   

Issues with the FDA could complicate Lilly’s efforts to win an emergency use authorization for its antibody treatment for COVID-19. The company has already submitted an EUA application, but also announced this week that it has paused a trial of the treatment due to safety concerns.