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A few days ago, @alt_fda dropped a pretty great thread about ibuprofen, contamination, & quality concerns.
If you haven't read it, please do so before continuing on this thread.
A few days ago, @alt_fda dropped a pretty great thread about ibuprofen, contamination, & quality concerns.
If you haven't read it, please do so before continuing on this thread.
This caused me to deep dive into those thoughts & follow the evidence, which led me to a singular conclusion regarding the mystery company referred to in the thread.
I need to lay some ground work so please follow along:
I need to lay some ground work so please follow along:
Americans rely on Gov oversight to protect the quality & safety of everything from airbags to eggs to medicine.
Companies are required to submit products for testing & submit to compliance inspections in an effort to protect the populous.
When those products are manufactured
Companies are required to submit products for testing & submit to compliance inspections in an effort to protect the populous.
When those products are manufactured
in the US inspectors have a home field advantage & exercise that to the benefit of the citizens.
When meds were being produced in Puerto Rico, oversight was good. However after Hurricane Maria plants were permanently shuttered & meds like ibuprofen began to
When meds were being produced in Puerto Rico, oversight was good. However after Hurricane Maria plants were permanently shuttered & meds like ibuprofen began to
be manufactured in less than scrupulous countries such as India & China where inspection protocols are laughable. Inspectors have to call ahead & schedule what would otherwise be a "surprise visit" days and weeks in advance giving the facility ample time to prep to pass,
destroy or alter documents, & reset machinery.
One company in particular, Perrigo, is a manufacturer of ibuprofen as both a store brand generic & brand name (Advil for ex) and imports mass quantities from China.
One company in particular, Perrigo, is a manufacturer of ibuprofen as both a store brand generic & brand name (Advil for ex) and imports mass quantities from China.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
Perrigo has received EIGHT 483 letters in the last two months. This is a big number in a short period of time.
Perrigo owns & operates its plants in China. When the API (Active Pharmaceutical Ingredient), in this case, ibuprofen, is imported into the US, it is sent to their facility in Michigan for final production. The CoAs (clinical outcome assessments) travel with these lots.
These lots are then turned into some store brands (generic) & name brands that enter the market place, your medicine cabinet, & ultimately you & your family.
So, what company:
1. Makes copious amounts of ibuprofen?
2. Handles name brands & generics?
3. Has manufacturing in China with poor oversight?
4. Has 8 483 letters?
Only one: Perrigo.
Prove me wrong.
1. Makes copious amounts of ibuprofen?
2. Handles name brands & generics?
3. Has manufacturing in China with poor oversight?
4. Has 8 483 letters?
Only one: Perrigo.
Prove me wrong.
