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FDA/ORA Efforts to Ensure Product Safety


Drug tampering and product
substitution in healthcare facilities

Article by Catherine Hermsen,
Assistant Commissioner
for Criminal Investigations, FDA/OCI
(Journal of Healthcare Protection

The FDA’s Office of Regulatory Affairs (ORA) uses a robust, risk-based oversight approach to ensure the safety of foods, drugs, and medical products for all Americans. 

Our multi-pronged efforts include: 

Keeping Watch During the COVID-19 Pandemic 

The pandemic posed unique challenges to our usual “on the frontlines” regulatory efforts, but ORA readily adapted, both logistically and technologically, to ensure continued protection of public health. We expanded use of our remote surveillance tools and employed other oversight approaches too—all while remaining vigilant about protecting the public, employees at the firms FDA inspects, and our staff from the continued harms of COVID-19. 

The Resiliency Roadmap for FDA Inspectional Oversight detailed these efforts and outlined our plans for returning to a more traditional state of inspections and oversight. 

And for more on how we exceeded our goals, despite the steep challenges of a global pandemic, we welcome you to read our 2021 annual report

FY21 Highlights

  • Exceeded its goals for completing domestic surveillance inspections as outlined in the Resiliency Roadmap’s “base-case scenario.” 
  • Completed inspections and/or assessments in support of all seven of the identified mission critical applications.  
  • Made decisions on nearly half of the 68 applications reported as delayed due to a pending inspection or assessment in the Resiliency Roadmap.   
  • Exceeded its goal related to following up on previous inspections classified as official action indicated (OAI). 
  • Made more than 1,300 requests to human and animal drug and biological product manufacturers to submit records for review, which supported timely regulatory decisions.  
  • Conducted more than 130 remote regulatory assessments under the bioresearch monitoring program that were directly used in application decisions. 
FY21 ORA Accomplishment Highlights

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