Understanding FDA Post-Warning Letter Meetings Under GDUFA III

The U.S. Food and Drug Administration (FDA) issues Warning Letters to companies or individuals when it identifies violations that may affect the safety, quality, or effectiveness of regulated products. Most Warning Letters follow inspections and require firms to take corrective actions.

As part of program enhancements under the Generic Drug User Fee Amendments (GDUFA III Commitment Letter), facilities receiving Warning Letters may be eligible to request a Post-Warning Letter Meeting with FDA. These meetings provide companies with an opportunity to engage directly with the Agency, clarify issues raised, present their corrective action plans, and receive preliminary feedback on whether the proposed measures appear adequate.

This mechanism was negotiated between FDA and industry to improve transparency and promote timely compliance. While not all companies pursue this option, Post-Warning Letter Meetings can be a valuable forum for resolving concerns and establishing a clear regulatory path forward.

18-08-2025