What The FDA’s Inspections Q&A Guidance Really Means: It’s Time To Offer Virtual Inspections
Compliance experts see possibilities in offering video tours as the FDA offers “holistic” approach to assessing sites during pandemic.
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The agency is resuming domestic inspections using a pandemic rating system to identify localities where inspections will be safest for investigators and plant workers. Another safety factor: all inspections will be pre-announced.
Phased approach will prioritize the safety of FDA and industry employees while striking ‘an appropriate balance between a scaled-back surveillance inspection program and the continuation of providing robust regulatory oversight,’ Commissioner Hahn says in a memo from self-isolation.