Eli Lilly said it received an Official Action Indicated notice for its plant in Branchburg, N.J., after FDA inspectors had some findings related to data handling.
- Plant is among several worldwide that produces bamlanivimab, one of the co.’s Covid-19 neutralizing antibodies
- Co. says issues raised during the Branchburg inspections have its full attention
- Has engaged an external consultant to conduct a comprehensive independent review of systems
- Has increased staffing and resources
- Confident that the issues raised during the Branchburg inspections didn’t impact product quality or patient safety
- Didn’t get a warning letter or other enforcement letter from the FDA related ...
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