{"id":"SEC-10-GM-031","kind":"meeting","level":"organizer","jurisdiction":"Regulated plants nationwide, ALL","state":"","metro":"","industry":"10","agency":"","eco":"","issuer":"U.S. Food and Drug Administration; accredited registrars; customers","authority":"","instrument":"FDA Resiliency Roadmap Inspectional Oversight","title":"Regulatory and certification inspections at manufacturing plants (FDA facility inspections; ISO registrar and customer quality audits) (class)","dateIssued":"2021-05-05","effective":"","end":"","startDate":"2021-05-05","endDate":"","quarters":["2021Q2"],"types":[],"addressees":[],"clause":"FDA (May 2021): \u0027the U.S. Food and Drug Administration made the decision to pause most foreign and domestic inspections, with the exception of mission-critical inspectional work\u0027","enforcement":"","functions":["PF","SC","CB","EN","DS"],"notes":"2020: FDA paused most routine foreign inspections (Mar. 10, 2020) and domestic surveillance inspections (Mar. 18, 2020); prioritized domestic inspections resumed July 2020; the backlog of postponed inspections carried into 2021; registrar and customer audits moved to remote formats under the same orders. 2021: FDA\u0027s May 2021 roadmap set out \u0027how we plan to address postponed inspectional work using a risk-based approach\u0027; foreign inspections remained largely paused through Q3 2021. Usual dates: Continuous. Scale: FDA: \u0027In March 2020... the U.S. Food and Drug Administration made the decision to pause most foreign and domestic inspections, with the exception of mission-critical inspectional work\u0027; \u0027In July 2020, we resumed certain domestic inspections in a prioritized fashion after developing a COVID-19 Advisory Rating system\u0027 (FDA Resiliency Roadmap, May 2021). Venue orders 2020: SEC-10-GM-031. Venue orders 2021: SEC-10-GM-031.","sourceUrl":"https://www.fda.gov/media/148197/download","snapshot":"","fileExists":true,"fileBytes":5577287,"grade":"primary","character":"","description":"FDA Resiliency Roadmap Inspectional Oversight","collection":"SEC-10","url":"/library/SEC-10-GM-031","exhibitUrl":"/exhibit/SEC-10-GM-031","citation":"U.S. Food and Drug Administration; accredited registrars; customers, FDA Resiliency Roadmap Inspectional Oversight (May 5, 2021) (Ex. SEC-10-GM-031)","stateName":"","related":[]}