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COVID-19: FDA introduces new risk assessment system for inspections

The U.S. Food & Drug Administration (FDA) is preparing to resume domestic inspections with a new risk assessment system. Due to the corona pandemic, restrictions have been in place since March.

In order to continue to bring safe products onto the market or to monitor them on a risk-based and qualitative basis, guidelines and processes have been revised and adapted to the situation. With the “COVID-19 Advisory Rating System”, FDA inspectors will determine the safety situation and prioritize domestic inspections accordingly.

The prioritized inspections will be announced to the pharmaceutical company in the future for the safety of the employees and the inspector. In addition, the inspectors will be provided with protective clothing and materials to enable them to perform their work in accordance with the applicable regulations.

 

Click here for the > FDA statement.

 

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