You can search on the web for ‘FDA consent decree’ and you’ll get a whole long list - or go to the FDA website and search for enforcement action. You can also look up the previous step to a CD which is typically a warning letter ... unless the company has been so egregious that they were knowingly shipping bad product.
This past year the big news was around 2 of Olympus’ plants in Japan receiving warning letters - their VP of quality was actually extradited and tried in NY. He just got probation, but that is mainly because he didn’t fight the extradition and also ‘retired’. He’d have been blacklisted from the industry by the FDA anyway based on what I understand the circumstances are.
The Consent decrees I’ve been involved in to some extent were: GE Salt Lack City (bit role), Invacare, and Terumo...also a voluntary shutdown at a site by Philips to avoid a CD. ALL the major device companies (except Boston Scientific) and
a large number of the pharmaceuticals have been hit with CDs since the FDA ramped up enforcement following the Guidant pacemaker recall sometime around 2002ish. Most are specific to a product line and/or plant - it’s rare that it gets to an entire corporation level.
So Medtronic, Abbott, GE, Philips, Baxter, and a large number of others have had one in the past 20 years - most take 4-8 years to clear in the meantime you have outside experts coming in looking at your operation in minute detail to make sure you’re making progress in the right direction.
Only once the FDA approved 3rd party recommends to the FDA you’re ready then the FDA will come back in and do their own inspection. Oh, and you have to pay for the 3rd party not the FDA. More than a few have decided to close a plant or stop producing a product because of the cost.
https://freerepublic.com/focus/news/4207228/posts?page=1
Hillary’s Comeback
Sultan Knish ^ | Daniel Greenfield
Posted on 1/2/2024, 9:13:34 AM by yldstrk
In a career low, Hillary was reduced to marketing fanfic in which she’s struggling with “a Republican president nicknamed ‘President Dumb’ who pulls out of the Iran Deal and then goes to Florida to play golf” and still couldn’t get anyone to pick up a copy. That and trying to get people to buy memberships to Masterclass to listen to her talk about the “power of resilience” put her only a step above peddling Cameo clips side by side with George Santos.
(funny as a heart attack..)