new drug application

FDA Warning Letter to Sponsor – Records, Reports, and Audit Trails

FDA Warning Letter to Sponsor – Records, Reports, and Audit Trails

04/22/2025

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In November 2024, the US Food and Drug Administration (FDA) issued a warning letter to the sponsor as a result of a BioResearch Monitoring Program (BIMO) inspection which observed objectionable conditions. The warning letter cited two violations of the Title 21 CFR.