A challenge with interpreting 483s that are issued to firms other than your own is that 483s don’t provide the context for what occurred during the inspection and how the issues were identified. Thus, to evaluate the seriousness of a 483 and the potential for additional enforcement action, I ask the following questions.
Okay, let’s settle this once and for all. We wrote a series of posts that will give you an industry primer for what these Form FDA 483s are, why they’re important, how to avoid them, and how to respond to them.
Today, we cover the basics. Some of you pros out there know this stuff all too well…
I spoke to a former VP of quality at the PDA/FDA Joint Regulatory Conference. He said one of his bad 483s probably cost him $5 million. And that’s cheap – that’s just a 483. What about a warning letter? There is an even greater magnitude of reputation damage, impact on new drug approvals, etc. This post describes the full scope and includes articles/case studies.
While the drug GMPs haven’t changed much, if at all, in recent years, the FDA is planning for significant changes in how drug GMP inspections are scheduled and conducted. Last year, the FDA made available a description of their new operating model that will ensure integration of review and inspection activities for human drugs. This post dives deep into this model – including new timelines for those of us in the drug industry.
Form FDA 483s are central to anyone’s FDA inspection preparation program. As the keeper of the world’s largest database of FDA 483s, we often get