Surprise US FDA Facility Inspections Resume In India
Unannounced facility visits also were to start again in China, but FDA Commissioner Robert Califf said they have been delayed by the COVID-19 outbreak in the country.
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One switch raised questions, but by the time the COVID-19 vaccine reached commercial scale, the changes were considered minor.
Poor inspection history was dropped as a criteria for unannounced inspections, OIG says in an audit report, even as support grows for surprise inspections of poor quality sites. An exhaustive review of foreign for-cause inspections shows the FDA reorganization has sped up a process that must go faster still. Meanwhile, whatever happened to experienced investigators’ training records?
System likely will evolve as post-pandemic world unfolds, but adds to list of agency programs expecting to continue using virtual platforms once in-person activities are no longer restricted by COVID-19.