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?
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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?