phoenixgsu t1_jdk6tjg wrote

I work in the industry. India is pretty bad about quality systems and regulatory conformance. There's a book called Bottle of Lies that goes into how bad it is. Companies in India are still subject to FDA law if it's on the market here in the US. If the law was followed this wouldn't have happened because the regulations stipulate what is required for good manufacturing practices, so it shouldn't have bacteria in it at all. Even if it did for some reason it should have been caught by sterility testing but it seems like they didn't do that or falsified the records.

FDA needs to crack down on overseas manufacturers.