For clinical researchers, our “grade card” comes when the FDA inspects us. We all want to be told that we’ve operated in a compliant manner and that there were no findings. The alternative is to receive a Form FDA 483 (483) for significant deviations at the close of the inspection. When I got my first 483 as a research coordinator 18 years ago, I remember thinking to myself “I’m not going to let that happen again.” In my opinion, it was an indication that we had not delivered A+ work. Since the stakes are so high in this environment, and we’re asking patients to trust us to perform, it was a big wake up call for me.
I now run a CRO and have worked for 16 years with hundreds of sites who are conducting research. I consider their success my report card now. While I was able to go well over a decade before one of those sites received a 483, I’ve noticed that recently, issuing a 483 seems more the norm as opposed to the exception. I would even go so far as to say that the findings in those 483s seem insignificant as opposed to significant. In some cases, the findings are not really even findings once reviewed in context.
When a 483 contains insignificant or unjustified findings, does it dilute the meaning of the 483 itself? Given the punitive nature of the 483s, should industry adjust their expectations as to what those 483s mean? Are the 483s diluted to the point where they don’t necessarily matter? Should FDA consider issuing them more selectively?
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