This guidance provides information on the implementation of the PostWarningLetterMeeting process for certain facilities, a program enhancement agreed upon by the Agency and industry as part of the negotiations relating to the reauthorization of the GenericDrugUserFeeAmendments as described in the “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027” (GDUFA III commitment letter).
A Post-Warning Letter Meeting, as described in section VII(D)of the GDUFA III commitment letter,is a meeting with FDA regarding the facility’s remediation of deficiencies identified in a warning letter.
This guidance specifically describes the process in the GDUFA III commitment letter for how an eligible facility may request a Post-Warning Letter Meeting with FDA regarding the
facility’s ongoing #remediation efforts to current good manufacturing practice (CGMP) deficiencies described in a warning letter, how to prepare and submit a complete #meetingrequestpackage, and how FDA intends to conduct the Post-Warning Letter Meeting.
In the GDUFA III commitment letter, FDA agreed to establish a Post-Warning Letter Meeting process for facilities to obtain preliminary feedback from FDA on the adequacy and completeness of corrective action and preventiveaction (CAPA)plans, to resolve the inspectional #deficiencies identified in the warning letter.
Consistent with the commitment letter,the FDA intends to grant a meeting request only if the facility meets the criteria discussed below and has submitted to FDA a thorough and complete CAPAplan that addresses all items cited in the warning letter, and reasonable progress has been made toward remediation.
Application-related discussions are not appropriate for Post-Warning Letter Meetings, even if FDA application assessors attend the meeting.
This guidance also does not address requests for re-inspections as described in the commitment letter.