The COVID Project
The record
- Jurisdiction
- Regulated plants nationwide, ALL
- Level
- Organizer
- Issued
- 2021-05-05 May 5, 2021
- In force
- May 5, 2021 (the notice's date)
- Quarters
- 2021 Q2
2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3
- Functions reached
- Collection
- Manufacturing SEC-10
Operative words
FDA (May 2021): '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'
The organizer's notice
FDA Resiliency Roadmap Inspectional Oversight
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's May 2021 roadmap set out 'how we plan to address postponed inspectional work using a risk-based approach'; foreign inspections remained largely paused through Q3 2021. Usual dates: Continuous. Scale: FDA: 'In 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'; 'In July 2020, we resumed certain domestic inspections in a prioritized fashion after developing a COVID-19 Advisory Rating system' (FDA Resiliency Roadmap, May 2021). Venue orders 2020: SEC-10-GM-031. Venue orders 2021: SEC-10-GM-031.