Ask the FDA anything about 483s

If you could ask the FDA anything about 483s or inspections anonymously, what would you ask?

We’ve been in talks with the FDA, and it’s highly likely that they will be willing to answer a list of thoughtful questions from us. As the 483 has received increasing attention, it is in everyone’s best interest to understand its nuances more deeply. If you want to submit a question, simply email me (tony at by Monday, July 29th. Of course, they won’t comment on anything that is speculative or personal in nature. However, if you have questions about policy, about how they think through decisions, procedural questions, etc, please send them along.

Some questions that we have already received:

Email me with your questions today at tony at

By the way, we are now in the process of uploading another 1,000+ FDA 483s into our store, bringing the total to be ~2,300 reports+. They will be available in our store on August 1, making FDAzilla the largest online 483 store anywhere.

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence.