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 FDAzilla.com) 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:
- Can you give us an overview of the internal processes around the FDA Form 483? Which of the inspectors write it, who must approve it before it goes out, how is it stored/logged, who redacts the information, etc?
- What criteria do you use to determine who is sent on any particular inspection? Why do some inspections involve 1 or 2 inspectors vs. 5 or 6?
- What criteria are utilized when inspectors tag an issue as a “repeat offense?” We’ve experienced this label applied more liberally in some aspects (e.g. quality systems) than others?
Email me with your questions today at tony at FDAzilla.com.
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 483s, Inspector Profiles, Enforcement Analytics, and GMP Regulatory Intelligence.