What happened
FDA describes GDUFA III facility-related commitments, including inspection transparency, communication of inspection information, and support for foreign regulators. For qualifying U.S.-based establishments included in foreign marketing applications, FDA will, upon written or email request, communicate the establishment’s current compliance status to the foreign regulator within 30 days. Following an inspection, an OAI classification means the firm’s CGMP compliance status is considered unacceptable. Certain OAI generic drug facilities may request a post-warning letter meeting or reinspection if all stated eligibility criteria are met. At post-warning letter meetings, FDA provides preliminary feedback on corrective action plans. Requests must list CAPAs undertaken and their current remediation status.
Why it matters
For generic drug manufacturers, the update may matter because an OAI classification can affect how FDA views a facility’s CGMP compliance, while eligible firms have defined routes to seek preliminary feedback on corrective action plans or reinspection. The required CAPA list and current remediation status make accurate corrective-action tracking and clear records particularly relevant when submitting a request. U.S. facilities supporting foreign applications may also use the described process for FDA communication of current compliance status to foreign regulators.
Key topics: GDUFA III facility inspection commitments, Post-warning letter meetings and reinspections, Foreign regulator compliance status communications