Does anyone know anything about the major FDA investigation or audit going on in Hayward? They showed up unannounced and have been onsite 2 weeks already. Are there some issues?
4 replies (most recent on top)
I don t see the issue in discussing this here. If the FDA does not find anything major then we can be proud to work for a company who puts patient and security first.
If not it is important that people are aware so that they can be more aware 9f possible issues and more easily raise them to put patient safety first.
Regulation and patient safety are expensive but crucial and should not be a taboo.
This has nothing to do with layoffs. Let’s not discuss legal issues on this forum.
I think it has to do with one of our customers using an RUO product for IVD purposes and one of our competitors blew the whistle with some regulatory body which triggered the audit. They were in SD too
I heard they were in SD too. I didn’t know they were there for two weeks. What happened?