by Tony Chen
Due to popular demand, we’ve started a website that’s focused solely on avoiding and responding to 483s. Check it out at FDA483s.com.
It’s still in beta phase and the paint is still drying, but I think you’ll get the picture of what this could be – a one-stop shop for resources, presentations, super-practical tips dedicated to avoiding Form FDA 483s. Please check it out and let us know what you think. Also, we’d love your contributions – the more you share, the more all of you will get out of this resource. We’ll work to aggregate and curate all of input and present in a way that’s organized and easy to digest.
It’s been great to already get some feedback (read the comment about having the “backroom” listening in on the inspector’s conversations with the senior people). We heard from one professional at a large biotech company who says she loves sharing her experiences about 483s. But to do so online, she’d have to have everything vetted by their legal department. So this gives her an outlet to do so anonymously. Another professional at a Fortune 50 company told me this week:
“My personal experience after an FDA inspection was to discuss my experience with as many people as possible so that I could do my part to improve my performance…much of a form 483 can be avoided with improved inspection performance.”
In addition, check out the 483s recent listing. While it’s still better to search our 10 years of 483s listings here on FDAzilla, I still found it oddly satisfying (yeah, I’m a nerd) to actually see just 2 months of 483s laid out there (all 1,600+ of them).
We’ve also started a new LinkedIn Group on Avoiding Form FDA 483s. This is a great way to ask and answer specific questions related to 483s. Since we know this can be a sensitive topic, simply email us at web at fdazilla dot com to send in a question or comment anonymously.
We invite for you to join us on this important topic. In the meantime, don’t forget to check out our list of 10 resources for avoiding 483s. Also check out our new research on 200+ 483s, resulting in a new report: the Top Seven Strategies to Avoid 483s