Here is a quick update on FDA Virtual Inspection Program;  

  • FDA’s long-awaited guidance on remote interactive facility evaluations is finally here: In November 2020, Pink Sheet reported that during an IPAC-RS virtual roundtable, deputy director of FDA’s Office of Policy for Pharmaceutical Quality, Brian Hasselbalch, stated that the FDA was developing guidance on remote evaluations, indicating that the Agency is considering virtual alternatives to on-site inspections. On April 14, 2021, that guidance was finally issued. Every RA/QA professional responsible for regulatory compliance should read it carefully and take the necessary steps to prepare for remote evaluation. Remote evaluations present their own challenges and may require special preparation. For example, employees communicating digitally may inadvertently create documents with risk implications for a company that wouldn’t be an issue with in-person discussions. 
    • Read the full guidance here.
    • Read our write-up of the key takeaways here.
    • Need expert auditing and inspection readiness support? Get in touch with us here. 
  • FDA’s large inspection backlog—and mounting pressure to address it—underscore the importance of facility readiness: In March 2021, FDA’s CDER reported that 90-day facility inspection classification letters were down 49% and that 38% fewer drugs had been added to the inspection refusal import alert than in the prior fiscal year. According to the GAO, the suspension of inspections has been delaying the approval of NDAs and NDA supplements with greater frequency. Once they resume, the stakes for successful in-person inspections are high because the continued backlog will likely result in significant delays in reinspection and resolution of an official action indicated (OAI) site classification. 
    • Read the full GAO report here.
    • Watch our interview with GAO’s Director of Health Care, Mary Denigan-Macauley on YouTube here.
    • Get in touch with us to discuss inspection readiness support here.
  Shall we have a “conversatorium” on how this virtual inspections are to change drastically the way we present our facility to the FDA, the 
way will it elevate the “Critical Systems” and Facilities to more in depth scrutinous for the Agency?
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