Julie Omohundro Since the article doesn't seem to provide any data on the warning letters issued for medical in previous years, it's hard to say.

Dorothy Erlanger Good point, Julie O.
Here's data re 2015 and 2016, from an FDA Ppt summary: 2015 121 WLs, 2016 57 WLs. Quite a swing.

Julie Omohundro Again, hard to say without earlier data, but based on these three data points, alone, it would seem that the turning point was 2016, not 2017. At the very least, this would exclude any relationship to the change of Administration last year.

As for the others, I have hard time thinking that those factors would occur so abruptly. I especially don't see the industry suddenly getting savvy from one year to the next. Would like to ponder this some more, but not sure I will be able to get back to it any time soon.

Dorothy Erlanger Julie O, agree that it couldn't be change of administration; happened before that and too quick a swing. It makes me wonder if there is a 4th factor in play here that they did not identify. They're assessing from a law review perspective.
I appreciate your comments!

Kris Kelly Spot on!

Keith DeBrunner Inspections and 483's were not down in 2017, but up. 483's in 2017 were higher than the previous three years (2017: 1030, 2016: 934, 2015: 1008, 2014: 972) (). A much lower number of WL's indicates that either MD manufacturers have increased their competence at closing their 483 issues, or the FDA has relaxed its escalation of 483's to WL's. This rules out CQI, and companies may not be more regulation savvy, but seem to be navigating 483 remediation more effectively. There is insufficient information to know, but I doubt the FDA is significantly more lenient than in previous years, though it may be they are unable to operate at the same pace as in previous years, so more time is being given before the 483 becomes a WL. Of other reasons, it seems likely to me that companies are getting better guidance and effectiveness from firms strong in remediation consulting and management.