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
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.
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The pandemic caused the US FDA’s Office of Regulatory Affairs to consider ways it can be more nimble in its inspectional activities, including launching an agency-wide council to tackle and solve inspection-related issues, the ORA’s Elizabeth Miller says.
FDA Warning Letter Recap, August 2021: On-Site Inspection Of Chinese Device Maker Uncovers Quality Systems Troubles
This is the first publicly released inspection-related warning letter sent to a Chinese company since the US FDA stopping sending investigators there in February 2020 because of the COVID-19 pandemic. A total of eight device-related missives were released by the agency in August.
Top leaders from all commodity centers within the FDA will take part in a new Inspectional Affairs Council that’s being stood up by the agency’s Office of Regulatory Affairs. Acting commissioner Janet Woodcock will also play a role.