With an increasing number of non-conformances, warning letters/OAIs for sites governed by US regulations, one has to ask what the missing link might be. Companies responding to regulatory actions need to create comprehensive responses that not only address their remediation plan, but also identify how they intend to ensure the sustainability of the remediated processes.
Surely, most companies participating this conference must have been through at least one USFDA physical audit. We are all fully aware that our expertise, presentation, knowledge, and behavior are important traits while facing agency investigators during inspection time. What is more important is our post-inspection behavior. How we read and understand a 483, how we respond, and how we communicate with the agency all play a vital role in how we will draw the closure lines. They can be good short ones or a very long one.
Response to a 483 observation is perhaps the last and best opportunity to tell your side of the story before many agency officials (compliance, enforcement, OMQ, OPQ, to name a few) who have not been to your facility and are unaware of what might have happened during the inspection. Form 483 is the living, guiding document for them to assess your facility and make some assumptions of what happened during inspection. You may be surprised to learn that FDA believes it is your responsibility to work with its investigators before they leave your facility to address any inaccuracies on the Form 483.
Fortunately, during these unprecedented times, the FDA has implemented an interim COVID-19 process for communicating with facilities following FDA review of records that will help companies to navigate the post-OAI requirements. Join us as we discuss how to create comprehensive responses to regulatory actions with industry peers, SMEs, and global regulators (USFDA, MHRA).