King & Spalding: FDA Inspections in 2021 for Drug and Device Manufacturers



12:00pm - 1:00pm

FDA suspended most field inspections of drug and device facilities in March 2020 due to the COVID-19 pandemic. In December 2020, FDA acknowledged the impact of the inspection hiatus on facility assessments necessary for pending drug and biologics applications. In addition, Agency officials have expressed skepticism about using alternative approaches for follow-up inspections of firms with problematic inspectional histories, noting that many follow-up inspections have revealed that earlier problems persist.

FDA inspections likely will resume sometime in 2021. Until then, we recommend that industry work to stay “audit ready” by conducting gap assessments and mock inspections, training specialized staff, and monitoring and correcting known deficiencies. This webinar will:
• Review FDA’s guidances and policy statements regarding manufacturing, supply chain and facility inspections during the COVID-19 pandemic.
• Provide recommendations for managing virtual audits and conformity assessments being conducted by Notified Bodies and MDSAP auditing organizations.
• Provide advice about managing requests for documents made under FD&C Act § 704(a)(4) and discuss how FDA is using the information obtained to plan future on-site inspections.
• Discuss potential alternatives to in-person inspections (e.g., Remote Regulatory Assessments) and whether and when they are viable for particular manufacturers.
• Recommend actions that drug and device manufacturers should be taking now, while most FDA inspections are suspended, to prepare for the day when audits resume in their regular form.

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Contact: Miranda Holizna
Contact Phone: 202 215 8592
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