Form FDA 483

3 Quick (but Proven) CMO Tips you Missed at the PDA Event

Every day I work with companies that are looking to find innovative solutions that mitigate compliance risk. I was invited to PDA Midwest's Risk Mitigation & Sterility Assurance Event to share what FDAzilla has found the best practices in supply chain risk mitigation are. In case you missed it, here they are.

6 Features to Look for in FDA 483s

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.

What’s the Big Deal with Form FDA 483s?

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…