FDA Completes Several GDUFA II Commitments to Provide Greater Transparency Regarding Facility Inspections

The FDA has completed several commitments under the Generic Drug User Fee Amendments of 2017 (GDUFA II) program, to provide greater transparency regarding prioritization and scheduling of inspections, as well as communicating information following inspections. These efforts include updating the FDA’s publicly available inspection classifications database, communicating with foreign regulatory authorities regarding the compliance status of establishments, providing information on the Agency’s risk-based site selection model, and communicating information from inspections that may impact approvability to applicants and facility owners.  The inspection classifications database provides the most recent classifications based on the FDA’s final assessments following an inspection of manufacturing facilities for routine surveillance purposes and sites conducting bioequivalence/bioavailability studies. The Agency updates the database every 30 days. Previously, the Agency updated the database every 180 days and did not include inspection classifications of sites conducting clinical bioequivalence/bioavailability studies.  The Agency also updated the database to build on our progress implementing the Mutual Recognition Agreement with the European Union, and it now supports inclusion of facility status based on classification of inspection reports from foreign regulatory authorities. Under GDUFA II, the FDA committed to updating the inspection classifications database by January 1, 2019 and to continue to update it every 30 days. Due to the interest in making this information available to drug manufacturers, applicants, foreign regulators, and the public, the FDA worked diligently to complete the commitment in advance of that goal. The FDA’s Office of Regulatory Affairs worked with the Agency’s product Centers to go beyond the commitment by including available information and updating the database every 30 days for inspections of all FDA-regulated medical products. For additional information regarding the other commitments and the FDA’s efforts to provide more transparent and timely information regarding inspections, visit the GDUFA II Facilities Enhancements webpage.