Demystifying FDA’s Switching Approach Towards Inspection

Whitepaper | November, 2021

For ages, the FDA has played a crucial role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic and other such conditions. However, businesses and regulators in the future will have to re-think and re-design their “priority within priority”, which is one of the read-between-the-lines messages observed from FDA’s inspection trend.

During the pandemic, FDA’s effort has been phenomenal while maintaining the safety and efficacy of drugs, biologicals, vaccines and medical devices. Mission-critical inspections and COVID-19 advisory rating systems were two such important strategies implemented by FDA to prioritize their roles and responsibilities and utilize available resources. Between March 2020 and 2021, FDA conducted 821 mission-critical inspections, which included inspections in 29 foreign countries.

The pandemic (COVID-19) has compelled the FDA to rethink about redesigning their inspection methodologies going forward. In response, manufacturers will need to re-define their quality and regulatory operations. It’s time to reconsider investing in tools and technology related to remote evaluations or audits. Know more in this whitepaper.

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