Guidance Breakdown: Requesting Post-Warning Letter Meetings Under GDUFA
What GDUFA III facilities must do—step by step.
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The FDA’s newly finalized “Post-Warning Letter Meetings Under GDUFA” guidance turns a GDUFA III promise into a formal process that lets an Official Action Indicated (OAI) facility sit down with the FDA and vet its CAPA plan before the follow-up inspection—ideally shortening the path back to acceptable compliance.
Although FDA says the June 2025 final carries only minor clarity edits to the 2023 draft, it now locks in timelines, eligibility rules, and decision goals the generics industry can plan around.
Here’s who’s impacted by this:
Facilities holding an FDA Establishment Identifier (FEI) that manufacture or process human generic drugs (API or finished dosage forms) at a single geographic site—that is the definition of a “facility” in section 744A(6)(A) of the FD&C Act referenced in the guidance.
Those facilities that currently hold an OAI status due to cGMP deficiencies cited during an FDA inspection and that subsequently received a warning letter.
Only facilities that are covered by the Generic Drug User Fee Amendments (GDUFA III) program—i.e., they have either paid the current-year GDUFA facility fee or are named in a pending ANDA.
Facilities whose warning letters address violations of section 501 of the FD&C Act related to human-drug manufacturing (including drug-device combination products); device-only or other product violations are outside the scope.
Each FEI affected by a warning letter is treated independently. A corporate group with multiple sites must consider the guidance separately for every establishment that received a warning letter. Third-party stakeholders—e.g., ANDA sponsors, customers, contract manufacturers not operating under the FEI in question—cannot request these meetings. Only the facility itself, its parent company, or an authorized legal representative may do so.
Here’s our quick breakdown.
If you haven’t already read our handy explainer for responding to 483s, warning letters, and consent decrees, grab the PDF here and keep it for if and when you need it. We explain our process for response and remediation in detail.
Performance goals and timeline
The FDA has committed itself to deciding whether it will grant, deny, or defer a meeting within 30 days for an increasing share of eligible requests:
50% in FY 2024
70% in FY 2025
80% in FY 2026–27
A standard meeting takes place ≈ 6 months after the facility’s initial warning-letter response, but the agency can allow an earlier slot if both sides would benefit.
Materials must reach the FDA 30 calendar days before the agreed-upon date.
Are you eligible?
A facility can ask for one of these meetings only when:
Its CGMP status is OAI following an FDA inspection.
It has paid the current-year GDUFA facility fee (or is listed in a pending ANDA).
The warning letter cites human-drug CGMP violations (device-related 820 issues are still fair game for discussion).
Each FEI gets two bites at the apple per warning letter. If the first request is denied, the second cannot be filed for at least 3 months.
How to request a meeting
Who may file: Only the facility, its parent, or an authorized legal rep—no applicants or customers.
Where to file: Email the request and package to FDA-GDUFAIII-PostWarningLetterandReinspectionRequests@fda.hhs.gov to secure a goal date.
When to file: After the 15-day warning-letter response window has closed—FDA expects evidence of progress, not promises.
Building a winning meeting package
The FDA will grant a meeting only if the package shows a thorough, systemic CAPA plan and reasonable progress.
Your submission should include:
Facility basics: Name, address, FEI, warning-letter number, fee status, and whether this is the first or second request.
Logistics: Preferred dates, non-availability windows, requested format (video, tele-, or face-to-face), and a one-hour agenda with time allotments.
CAPA summary table: for every deviation: root-cause analysis, product and systemic impact, CAPA owner, interim controls, target completion date, and percent complete. Include remediation for the Form 483 items even if not in the warning letter.
Key questions you want the FDA to answer about CAPA adequacy. Be realistic about what fits in the hour.
How the FDA responds
The agency will make one of three decisions:
Grant Agency emails date, time, place, and its attendee list.
Deny: Common triggers include a CAPA plan that is incomplete, weak progress evidence, or missing package elements.
Defer: The FDA decides a re-inspection is the better next step.
Rescheduling and canceling
Either side can reschedule for emergencies, missing data, or unanticipated FDA participation. Cancellations by the facility count as its second and final request. The FDA may cancel if it opts to inspect instead.
Inside the one-hour meeting
The FDA chairs the meeting, sets the clock, and expects a tight flow: introductions, brief facility presentation, at least 30 minutes of Q&A on CAPA progress, and clear action items before closing. Firms may keep their own minutes; FDA will not sign off on them.
A few action items we recommend
Here are detailed steps we recommend teams consider to operationalize this guidance:
Close the 15-day gap first. File a substantive warning-letter response, then give yourself time to generate progress before requesting a meeting. (Talk to us the moment you receive a warning letter. We can stand up a consultant or team within 24 hours with a clear playbook to run.)
Run an OAI remediation dashboard tracking each deviation’s root cause, CAPA owner, milestone dates, and percent complete so you can drop data straight into the FDA’s table format.
Book your slot strategically. Our advice is to aim to send the request around Month 4, giving FDA two months to decide and leaving you a cushion before the 6-month default date.
Prove progress—don’t promise. Attach executed batch records, completed training logs, and photo evidence of facility upgrades to show momentum.
Vet the package internally first. Pull QA, Operations, and Engineering into a mock review to spot missing cross-facility CAPAs or weak timelines. This is a huge reason firms hire consultants to augment their internal team. We routinely catch issues that internal teams can’t or won’t see due to internal bias, company politics, etc. The FDA loves to see firms contract with outside experts.
Rehearse the hour. Script a 10-minute slide deck and allot a full half-hour to FDA questions. Bring SMEs who can answer without deferring.
Plan for both outcomes. If the FDA defers to inspection, have your audit readiness playbook ready; if it grants the meeting, update your CAPA schedule to incorporate FDA feedback immediately.
Keep warning-letter updates flowing. Continue periodic written updates between the request and the meeting; they demonstrate engagement and may head off follow-up questions.
Need help stress-testing your meeting package?
The FDA Group’s former investigators and compliance leads can run a mock FDA review of your CAPA plan, tighten your evidence set, and coach your presenters so you walk into the meeting ready to close your OAI chapter. We help firms respond effectively to enforcement actions and remediate on the other side. Drop us a line to start the conversation.
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