USFDA issues new draft guidance for Post-Warning Letter Meetings for facilities issued a Warning Letter Read More..

As per the GDUFA III commitment letter, USFDA has issued a draft guidance for facilities to request a Post Warning Letter Meeting. It is a meeting with FDA regarding the facility’s ongoing remediation efforts of deficiencies identified in a Warning letter; for facilities to obtain preliminary feedback from FDA on the adequacy and completeness of corrective action and preventive action (CAPA). A Post-Warning Letter Meeting will generally take place 6 months or later after initial response to Warning letter. A facility may request for a meeting prior to 6 months which FDA may grant if is beneficial to both parties.  Facilities with a cGMP status as OAI (Official Action Indicated), has paid the GDUFA fee or is named in a pending ANDA application and deviations are related to manufacturing of human drugs or drug-device combinations are eligible to request a Post Warning Letter Meeting. The meeting could be via video conference, teleconference, or face-to-face at FDA’s discretion.

A complete meeting package to request a Post Warning Letter Meeting should be submitted electronically, consist of a CAPA plan and supplementary information to demonstrate actions in progress for systematic remediation of deficient practices. FDA expects reasonable progress toward remediation is unlikely if a Post Warning letter meeting request is submitted with or around the submission of response to Warning letter. The request for a Post Warning Letter Meeting should be submitted in a separate and subsequent submission. A facility should also continue to submit Warning letter responses and any subsequent updates to FDA as described in the warning letter.

The meeting package should show facility has made reasonable progress towards remediation and should provide specific information relevant to discussion topics. A Post Warning Letter Meeting to include discussion of remediation activities of all deviations identified in the inspection (cited in the 483, verbal observations) whether or not those issues were included in the Warning letter. The meeting package should include a description of the root cause analysis and a retrospective evaluation of the impact of each deficiency on product quality and other systems and CAPA plan with timeline and status; if previous or post-warning letter inspections are also classified as OAI, a summary of those CAPAs and completion status should be included as well. The meeting package should also include a list of key questions that can be reasonably discussed within the scheduled meeting time. FDA will review the request and the facility will be notified of the FDA decision to grant, deny, or defer the Post-Warning Letter Meeting. A Post Warning Letter meeting is granted only if facility has submitted a comprehensive CAPA plan addressing all items in Warning letter and reasonable progress is made toward remediation. FDA can deny the Post Warning Letter Meeting request if the package is inadequate, incomplete, for e.g. it does not include a retrospective evaluation of the scope of issues. A facility is allowed only two requests for a Post-Warning Letter Meeting per Warning letter. If a meeting request is denied, a facility can request a second (and final) Post Warning letter meeting after 3 months of the first denial. FDA may also defer a Post Warning letter meeting if FDA determines a re-inspection is the appropriate step and notify the facility for re-inspection.

Draft Guidance