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Wednesday, November 4, 2020

Lilly updates on FDA surveillance inspections

  • Given recent interest in two routine FDA general surveillance inspections of Eli Lilly's (NYSE:LLY) manufacturing facility in Branchburg, NJ, the company provides an update on its remediation activities to date.
  • The company has performed in-depth investigations into each of the FDA’s areas of concern, and has either completed its remediation activities or has put enhanced interim controls in place while its improvements are completed.
  • Lilly has confirmed that there was no impact on product quality. In addition, the company is taking a comprehensive look at data integrity for the Branchburg site.
  • All active pharmaceutical ingredients delivered from Lilly Branchburg are subject to further quality assurance steps when turned into medicine at other sites.
  • The company's goal is to ensure that the Branchburg facility meets all of the FDA’s rigorous Good Manufacturing Practices (GMP) and quality standards.
  • https://seekingalpha.com/news/3630908-lilly-updates-on-fda-surveillance-inspections

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