3 ms·
You should take a look at the documents I FOIAd from FDA (the parts they didn't redact that is--apparently my appeal will take 3 years to be processed). Median
by morpheuskafka 8y ago
You should take a look at the documents I FOIAd from FDA (the parts they didn't redact that is--apparently my appeal will take 3 years to be processed). Median Medical Technologies, Inc. (a Pfizer company that produces and owns patents for the EpiPen) violated numerous safety rules and breached aseptic manufacturing multiple times, and did not appropriately investigate failures.
Here's one of their violation letters, I was told that sanctions were still being considered for the latest inspection.
https://www.fda.gov/iceci/enforcementactions/warningletters/2017/ucm574981.htm https://www.fda.gov/iceci/enforcementactions/warningletters/...
https://drive.google.com/drive/folders/1BgduIfkAL4SaYVQu1yyJXp08q9kJJGa7?usp=sharing https://drive.google.com/drive/folders/1BgduIfkAL4SaYVQu1yyJ...