483 << and that most are never reported since they are considered non-material.>>
I have worked on the IT side of the pharmaceutical industry, and my experience was that every 483 was lethally important. Similar to there being no way to be "a little bit" pregnant.
Cost and difficulty of resolution certainly varied, but the 483 itself goes straight from FDA to CEO, then all hell breaks loose (or should), regardless of how "minor" resolution might be. Every 483 effectively constituted a cease-operations order.
The 483 non-disclosure has been the most meaningful and disconcerting thing to me regarding the "truthiness" of Gold et al, and I would love to see the citation itself. I was surprised it was not a focus of the first lawsuit, since it seemed such an easy point of complaint.
A wild guess influenced by my IT worldview: Best case may be that the 483 was focused on Electronic Records and Signatures issues. Over the past 10 years ERS has evolved hugely with FDA (just google '21 cfr part 11') and it can be relatively easy pickens for inspectors, both because it is a new area and compliance complex to understand. But fixes can be easy, focused on procedural changes, documentation, or even training. Or it could require a complete application replacement or revalidation. Much more time and money is spent documenting and validating pharma applicaitons than developing them.
Note: The above is based on my last pharma work, which was about 6 years ago and involved big pharma, not a startup. But based on dicussions with friends still in that industry, I believe ERS is still a very big issue. And I don't think anything has changed about 483s -- no programmer, project leader, plant manager, division VP, or CEO wants to get within a mile of one.
Would be interested to hear from anyone more recently or more directly knowledgeable.
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