They do. 21CFR210,211, and others. Products are supposed to be made sterile by the manufacturing process and confirmed through testing. Bet this company did neither. Companies in India are really bad about this.

It is regulated. There are regulations for good manufacturing and good lab practices. The eye drops should have been sterile during the mfg process and even if they weren't it would have been caught by sterility testing. This company probably falsified a ton of records.

Lots of bacteria are salt tolerant, and saline water has hardly any salt in it to begin with. Further, pseudomonas spp are a know human pathogen, company should have caught it in sterility testing but of course these companies in cut corners and falsify records.

Just avoid all medical products made in India. Quality control is a major issue there.

I work in the industry on the quality and regulatory side of manufacturing. I wouldn't buy any product from India,any of these companies focus on generics and knockoffs and lack real GMP l, quality systems and quality control even though they are regulated by FDA.

You don't need chemicals in them to prevent this. You need quality systems in place and to follow FDA regulations to prevent them from being contaminated in the first place. Sterility testing is also required and Id bet money this company just falsified them.

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.

I'll just leave this here This too

Showing up at the border and applying for asylum and illegally crossing and getting caught are two different things. Unfortunately these two get treated the same. Everyone applying for asylum should be afforded a chance to make their case and have reasonable accommodations or sponsorship.