USFDA Guidance: Post-Warning Letter Meetings Under GDUFA III: A Regulatory Pathway Toward Compliance

Sharan Murugan
Jun 18
2 min read

In the evolving regulatory landscape of generic drug manufacturing, compliance and transparency are more crucial than ever. The FDA’s Post-Warning Letter Meeting process—introduced under GDUFA III (2023–2027)—provides facilities with a formal opportunity to engage with the Agency on their corrective and preventive action (CAPA) efforts following a warning letter.

This June 2025 guidance lays out a detailed roadmap for manufacturers to restore compliance, reduce regulatory uncertainty, and move toward potential re-inspection.

The Generic Drug User Fee Amendments (GDUFA), first enacted in 2012 and reauthorized every five years, empower the FDA to collect user fees from generic drug manufacturers. These resources enable the agency to expedite the review of generic drug applications and enhance regulatory oversight, ultimately improving patient access to safe, affordable medicines.

What Are Post-Warning Letter Meetings?

These are formal meetings requested by facilities that have received a warning letter following an inspection. The purpose is to obtain FDA feedback on whether the proposed CAPA plan sufficiently addresses the deficiencies cited in the warning letter, typically related to CGMP violations.

While not mandatory, these meetings can play a pivotal role in a facility’s regulatory recovery process and provide insight into whether a re-inspection may be warranted.

Under GDUFA III (2023–2027), the FDA has committed to timely responses to Post-Warning Letter Meeting requests:

FY 2024: 50% of eligible requests addressed within 30 days
FY 2025: 70% within 30 days
FY 2026 & 2027: 80% within 30 days

If a high rate of first-time meeting requests are denied, the FDA will provide additional guidance to industry to improve the process.

The Meeting Request Process

Preparing the Meeting Package

A comprehensive meeting package is essential and should include:

A thorough CAPA plan addressing all deficiencies cited in the warning letter.
Supplementary documentation demonstrating progress toward systemic remediation.
Clear objectives for the meeting and supporting data to facilitate discussion.

Submitting the Request

Requests should be submitted electronically to the FDA using secure email channels.
The package must be complete and detailed to avoid delays or denials.

Timing

Generally, meetings are scheduled six months or more after the facility’s initial response to the warning letter, but earlier meetings may be considered if beneficial.

FDA Assessment and Meeting Outcomes

Possible Outcomes

Granted: If the facility meets all criteria and has made reasonable remediation progress.
Denied: If the facility is not ready or the package is incomplete.
Deferred: In favor of a re-inspection if that is deemed more appropriate.

Conduct of Meetings

Meetings may be held via video conference, teleconference, or in person, at the FDA’s discretion.
Discussions focus strictly on remediation of CGMP deficiencies, not on application-related issues.

Rescheduling and Canceling

Requests to reschedule or cancel must be communicated promptly, with valid justification.

By understanding the eligibility criteria, preparing robust meeting packages, and following FDA procedures, manufacturers can expedite the path to regulatory resolution and ensure the continued supply of safe, effective generic medicines. For full details and the official guidance, visit: