Lilly hires outside advisor for COVID drug plant problems

▴ Lilly hires outside advisor for COVID drug plant problems
The company reiterated that it had not received a warning letter from the U.S. Food and Drugs Administration following inspections at the plant.

Eli Lilly and Co said late on Tuesday it had hired an independent consultant to review a plant producing its promising COVID-19 drug after receiving notices from the U.S. health regulator.

The company reiterated that it had not received a warning letter from the U.S. Food and Drugs Administration following inspections at the plant first revealed by Reuters last week.

The company, however, also reiterated that it had received an Official Action Indicated (OAI) notice from the FDA in relation to issues at its Branchburg plant in New Jersey.

The statement said, ''Recently, one of our manufacturing plants underwent a routine Food and Drug Administration (FDA) general surveillance inspection to examine our adherence to rigorous Good Manufacturing Practices (GMP) and quality standards set by the FDA. The inspectors had some findings related to data handling and thus we received an Official Action Indicated (OAI) notice. Given that this plant, located in Branchburg, NJ, is among several worldwide that produces bamlanivimab, one of our COVID-19 neutralizing antibodies, we wanted to share more information about our response to this confidential inspection given global interest in our treatment development efforts.

The issues raised during the Branchburg inspections have our full attention and we have been working closely with FDA on remediation efforts. Lilly has engaged an external consultant to conduct a comprehensive independent review of systems at the Branchburg site, and we have increased staffing and resources at Branchburg to manage the additional activity levels we are experiencing related to production of active pharmaceutical (API) ingredients.

We are confident that the issues raised during the Branchburg inspections did not impact product quality or patient safety. While Lilly has not received a warning letter or other enforcement letter from the FDA related to this matter, we nevertheless take all FDA inspection findings very seriously and are urgently working to address their concerns.

We have a robust, global supply chain in place to produce bamlanivimab, with Branchburg being one of five API manufacturing sites worldwide. And in anticipation of a potential approval, we have engaged an independent consultant to review our detailed Branchburg manufacturing and quality records for bamlanivimab.

We are confident in the quality systems for our global manufacturing processes. Our commitment to the safety of our medicines has not – and will not – change during our efforts to provide treatments to fight this global pandemic.''

ABOUT LILLY-

Lilly was founded in 1876 by Colonel Eli Lilly, a man committed to creating high-quality medicines that met real needs in an era of unreliable elixirs peddled by questionable characters. His charge to the generations of employees who have followed was this: "Take what you find here and make it better and better." 

Source- Reuters

Tags : #lilly #outsideadvisor #coviddrug #plantproblems #USFDA

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