oh boyyy. This is a doozy.

It's everywhere!! But for real though, my point was that the FDA is stopping shipments of ingredients coming out of these manufacturing facilities altogether- and they don't even need to crack open a box to do it. My guess is that this could tie into those gross HYALO Vials people mentioned last week. Sure, there will always be some workaround, but seriously, come on China. Get the factory clean!
 
bamagirl26 said:

It's everywhere!! But for real though, my point was that the FDA is stopping shipments of ingredients coming out of these manufacturing facilities altogether- and they don't even need to crack open a box to do it. My guess is that this could tie into those gross HYALO Vials people mentioned last week. Sure, there will always be some workaround, but seriously, come on China. Get the factory clean!
Click to expand...
Honestly, when it comes to supply chain risk, a facility making APIs that FDA inspectors actually visit would rank pretty low on my list of concerns.

And regarding problems, even here in the US, my guess is it resembles PPM.. sometimes ignorance really is bliss..

What Happens When You Ingest Mold

  • Stomach Breakdown: Mold cells and a lot of the compounds tied to them get broken down on their own by the acids and digestive enzymes in your stomach.
  • Mild Reaction: For the majority of healthy individuals, the only thing they notice is a bad taste that's earthy or like dirt.
  • Gastrointestinal Upset: Occasionally, people who are sensitive, or cases where a lot of contaminated food was eaten, can bring on minor stomach trouble, queasiness, or cramping. [1, 2, 3]

When Mold Is Dangerous

  • Mycotoxins: A few types of mold generate poisonous substances known as mycotoxins. When they show up in large quantities on particular grains, nuts, or food that has gone bad, the result can be serious poisoning, sharp stomach pain, or health problems down the road. [1, 2]
  • Food Safety Rule: The USDA Food Safety and Inspection Service says that any food with a lot of moisture (think lunch meats, cooked leftovers, soft cheeses, and baked goods) should be thrown out right away once mold is visible, since mold is able to work its way beneath the surface.
 
It strikes me as awfully convenient that the FDA just so happened to identify a substance that is extremely hard — and expensive — to test for with any accuracy, that wouldn't be caught by filtration, and that grows so slowly you couldn't spot any visible change or any shift in pH until long after the vial had already gone bad...

And I'm saying this as a person who has run quality audits at labs and production sites and has genuinely "seen some shit".
 
lalakelly said:

I'm not sure mycotoxins would be taken out by filtering.
Click to expand...
That checks out. Mycotoxins are tiny, low-molecular-weight chemical compounds — usually below 500–1,000 Daltons — while a typical 0.22 µm syringe filter only catches bigger physical particles, bacteria, and fungal spores. Getting rid of them takes solid-phase extraction (SPE) or immunoaffinity columns. Still, does anyone actually want all the gunk that a filter CAN catch? 🙂
 
GLiPtest said:

Yet that facility holds a license from the Chinese government to produce pharmaceutical active ingredients.

I'm confident the shadowy, unregulated basement operations run by Chinese criminals supplying the black market are far more diligent about their customers' wellbeing....
Click to expand...
I couldn't agree more!!!!! There's no question our labs are cleaner!




5fbea321da6d0d7684efa2afd5210917144c6b0e3068844fbb800105ced8dce6.gif
 
Back
Top