Re:Former Boeing 737 Max Chief Technical Pilot Indicted for ...
by HeyLaughingBoy on Friday October 15, 2021 @08:08PM
(#28884504)
And ISTR that just around the time I entered the medical device industry, that this is exactly what happened to Abbott and they were forced to remove some of their products from the market for months until they could bring their quality system back up to FDA satisfaction.
Hard to believe that it was so long ago. Man, I'm old :-) https://www.chicagotribune.com/news/ct-xpm-1999-11-03-991103...
I don't know much about the FAA, but as someone who works in healthcare, I know the FDA conducts regular audits of medical device manufacturers.
They roll in for a week, request access to everything and everywhere, then pick a handful of areas (randomly) to do a full deep-dive. Generally, if a company is cutting corners, discrepancies will exist in many areas and they'll quickly spot one or more of them. I assume the FAA operates similarly.