FDA Inspections Recommencing: Be Prepared - An NSF Guide
Are You Ready for an FDA Inspection? FDA inspections recommence on February 7, 2022. Are you ready? Sanjay Shetgar from NSF International has created a useful guide to help you prepare.
The FDA has restarted unannounced inspections of manufacturing facilities. The restart commenced on February 7. Inspections were halted in March 2020 with the outbreak of COVID-19. A limited number of inspections had restarted; however, they were again paused due to the emergence of the Omicron variant in December 2021. The agency plans to proceed with planned inspections in countries that have received country clearance and fall under the Centers for Disease Control and Prevention’s Level 1 or Level 2 COVID-19 travel recommendations. India and China belong to these categories. The FDA plans to restart additional foreign surveillance inspections in April.
Companies need to be ready for the restart of FDA inspections. NSF International’s global team of pharmaceutical and biotech experts is already assisting companies with their preparations.
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