The FDA Hasn't Inspected This Drug Factory After 7 Recalls for the Same Flaw

Re:The FDA Hasn't Inspected This Drug Factory After 7 Recall... by giantg2 on Thursday December 12, 2024 @01:52PM (#42402101)

"What can you say, this is what you get when you cut funding of these agencies over a 20+ year time period."

Actually, this is mostly an issue with process. Covid shutdowns caused a huge backlog. Offshore manufacturing gets notifications of planned visits versus unannounced visits for onshore facilities. Sure, every org will say it can do more with a bigger budget. But more money for inspectors will do little to retain them when some of the biggest complaints are the travel requirements leading to reduced work-life balance.

[ Parent | on HN ]

Re:The FDA Hasn't Inspected This Drug Factory After 7 Recall... by BadHumans on Thursday December 12, 2024 @01:55PM (#42402131)

You make it sound like you can't use money to hire more inspectors so the burden is reduced.

[ Parent | on HN ]

Re:The FDA Hasn't Inspected This Drug Factory After 7 Recall... by giantg2 on Thursday December 12, 2024 @03:57PM (#42403242)

You really think that will help? Even if you double staffed it, you're still looking at about 40% travel. People with lives and families don't want that. You could overstaff by 15% so attrition doesn't hurt as much, but there's a whole GAO report you could look up.

[ Parent | on HN ]

Re:The FDA Hasn't Inspected This Drug Factory After 7 Recall... by BadHumans on Thursday December 12, 2024 @04:58PM (#42403842)

> You really think that will help?

Yes.

[ Parent | on HN ]