Category: Audits and Inspections

  • Will FDA Inspections Ever Be the Same?

    FDA announced in July that it plans to resume inspections of some US-regulated facilities this week, but it s not clear how it will decide which sites to visit and what alternative oversight strategies will apply where on-site inspections are difficult. Yet, the resurgence in COVID-19 cases in t

  • FDA Works to Resume On-site Domestic Inspections

    FDA announced on July 10, 2020 that it was planning to restart inspections of domestic facilities the week of July 20, dependent on the trajectory of the virus in the state the facility is located as well as local government rules and guidelines. On-site surveillance inspections of US facilities