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FDA’s New Inspections Council Whipping Up Policy Around Remote Regulatory Assessments

Also: Agency carries out more domestic surveillance inspections in FY ’21 than anticipated

 
• By Shawn M. Schmitt

The US FDA says in a report that its Inspectional Affairs Council will develop Remote Regulatory Assessment policies for all commodities the agency oversees. RRAs were launched by the FDA as a way to check on a firm’s regulatory compliance without sending an investigator on-site.

Figurine of an industrial factory plant and a magnifying glass.
• Source: Alamy

One of the first jobs the US Food and Drug Administration’s new inspections council will take on is developing policy around the agency’s use of Remote Regulatory Assessments.

The FDA established its voluntary-for-industry RRA program in early 2021 as a way for the agency to check on a company’s regulatory compliance without having to send an investigator on-site...

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