FDA announced on July 10, 2020 its intention to resume prioritized domestic inspections beginning the week of July 20, 2020. The locations of inspections will be based on the COVID-19 virus’ trajectory in a given state and locality as well as the rules and guidelines that are put in place by state and local governments.
In order for FDA to determine safe locations for prioritized domestic inspections to occur, the Agency has developed a rating system based on real-time data and qualitative assessments of COVID-19 cases in local areas. The COVID-19 Advisory Rating system (COVID-19 Advisory Level) data will also be available to state partners who carry out inspections of FDA-regulated entities on the agency’s behalf under contract.
Additionally, with the exception of retail tobacco inspections, FDA has determined that, for the foreseeable future, prioritized domestic inspections will be pre-announced which will help assure the safety of the investigator and the firm’s employees, providing the safest possible environment to accomplish regulatory activities, while also ensuring the appropriate staff are on-site to assist FDA staff with inspection activities.
EAS Consulting Group assists firms with preparing for FDA audits as well as audit support through our mock-FDA inspections programs, desk audits of SOPs and data reviews. We can help to strengthen your GMP compliance by identifying gaps and facilitating corrective actions.
To learn more about FDA’s resumption of prioritized domestic inspections, click here.
To learn more about how EAS can help you to prepare, click here.
Posted in COVID-19.