Drugs

FDA Remote Inspections Could Continue After Pandemic: Attorneys

David McFarland

— 1 min read
Share

FDA’s willingness to embrace technology-enabled tools to conduct remote inspections and trim the mounting inspection backlog during the Covid-19 pandemic “may transform FDA’s inspection approach for years to come.” That’s the projection made by Sheppard Mullin attorneys Allison Fulton and Eva Schifni in their analysis of the agency’s 4/14 guidance on its policy for conducting remote evaluations during the pandemic.

The post notes that the Government Accountability Office recently urged the agency to reassess its inspection strategy to address its growing backlog. “Over the past decade and long before the Covid-19 public health emergency, FDA has struggled to streamline its inspection strategy to accommodate the increasingly global pharmaceutical supply chain,” Fulton and Schifni write. “The public health emergency and the accompanying safety concerns and travel restrictions have compounded this problem. During the public health emergency, FDA’s in-person inspections largely came to a halt, while other countries instead embraced other tools to conduct inspections with reliance on cameras, mobile Wi-Fi hotspots, Web conferencing, and confidential document-sharing tools.”

They say it is unlikely that in-person inspections will ever be fully abandoned because they enable unannounced inspections, provide a more holistic picture of facility cleanliness, and allow for real-time reaction and analysis.

In the guidance, FDA identified five inspection categories that would be considered for remote interactive evaluations: pre-approval and pre-license inspections; post-approval inspections; surveillance inspections; follow-up and compliance inspections; and BIMO (bioresearch monitoring) inspections.

To complete a remote evaluation, FDA may: 

  •          request and review documents, records, and other information ahead of and during the evaluation;
  •          use livestream and/or pre-recorded video to examine facilities, operations, data, and other information;
  •          schedule interviews and meetings to address any questions or concerns;
  •          evaluate a facility’s corrective actions, often in response to a previous inspection or evaluation; and
  •          provide verbal updates to the facility on observations and outstanding issues.

Written evaluation observations will not be listed on an FDA-483 and will not be considered inspection observations. The post says FDA asks that facilities respond to the observations within 15 days.

Read more