On June 18, 2025, the Food and Drug Administration (FDA) issued a final guidance for generic drug manufacturers requesting post-warning letter meetings with the agency. The guidance applies to certain facilities engaged in active pharmaceutical ingredient or finished dosage form manufacturing. We previously provided a comprehensive outline of the September 2023 draft guidance.
As described in the Generic Drug User Fee Amendments (GDUFA) III commitment letter, a post-warning letter meeting provides an opportunity for an eligible facility to discuss with the FDA the facility’s remediation of current good manufacturing practice (CGMP) deficiencies identified in a warning letter.
Most of the FDA’s substantive recommendations in the final guidance remain unchanged from the draft guidance. The final guidance provides information on how an eligible facility can request a post-warning letter meeting, prepare, and submit a complete meeting package. The final guidance also describes the FDA’s process for conducting a post-warning letter meeting. Similar to the draft guidance, the final guidance does not directly address requests for re-inspections as described in the GDUFA III commitment letter.
Who May Submit a Request
The eligibility criteria for a facility to request a post-warning letter meeting has remained substantively the same. The facility must meet the following criteria:
- CGMP compliance status of the facility is official action indicated (OAI).
- The facility has paid a GDUFA facility fee for the current fiscal year, or is named in a pending abbreviated new drug application (ANDA).
- The regulatory action (e.g., warning letter) is limited only to violations and/or deviations from Section 501 of the Federal Food, Drug, and Cosmetic Act (FDCA) related to human drug manufacturing, including the manufacturing of a drug-device combination product.
In the final guidance, the FDA added a footnote stating that individual facilities that receive a warning letter (i.e., each facility denoted by separate FDA establishment identifier (FEI) that is issued a warning letter) may be eligible for a post-warning letter meeting.
Preparing a Meeting Package
The information for preparing and submitting a meeting package is virtually the same as in the draft guidance. As stated in the draft guidance, the meeting package should include the facility information, meeting logistics, and a summary of corrective and preventive actions (CAPAs), including a CAPA plan timeline.
In the final guidance, the FDA recommends including a list of key questions regarding the adequacy and completeness of the facility’s CAPAs that can be reasonably discussed within the scheduled meeting time. This differs slightly from its original recommendation in the draft guidance, which did not limit this recommendation to questions on CAPA adequacy and completeness.
Conducting Post-Warning Letter Meetings
Consistent with the procedures outlined in the draft guidance, the final guidance provides the following agenda items:
- Introductions.
- FDA opening remarks.
- Facility presentation of the CAPA plan progress and questions.
- FDA and facility discussion of the CAPA plan progress and facility questions (allowing for at least 30 minutes).
- Action items and next steps.
- Closing remarks by corporate or facility senior leadership.
- FDA closing remarks and discussion of any action items.
The final guidance cautions attendees not to take audio or visual recordings of discussions at the meetings. This is a shift from the draft guidance, which stated that the FDA did not intend to permit recording of these meetings without the FDA’s prior written consent. Companies should take note of this change and its relation to the FDA’s location in Maryland and the impacts of Maryland state law. Maryland is what is often referred to as a “two-party consent state.” Under the Maryland Wiretapping and Electronic Surveillance Act, consent of all parties to a conversation is required before commencing recording. Violation of this law is a felony, punishable by imprisonment for not more than five years and a fine of not more than $10,000.
Accordingly, companies should be cautious of using artificial intelligence (AI) meeting assistant tools during meetings with the FDA. These AI tools are generally used to transcribe and summarize online meetings and can be integrated into video conferencing platforms such as Zoom and Microsoft Teams. Most of these meeting assistant tools record audio from the meeting and then use AI software to transcribe the audio into a transcript that can be further summarized. Maryland’s two-party consent requirement also applies to the use of AI meeting assistant tools that record and transcribe meetings.
Alston & Bird regularly advises clients on post-warning letter meeting requests and assists clients in preparing meeting packages and presentations. If you have any questions or require assistance, please let us know.
If you have any questions, or would like additional information, please contact one of the attorneys on our FDA: Compliance & Enforcement team.
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