>>16561936 FDA Panel Advisor Admits Agency “LOST” Clinical Trial Data PB Notable
Poking around on the FDA site and found a page that allows a search of warning letters issued from the agency. Threw Pfizer into the search and it came up with a letter to '"Meridian Medical Technologies, a Pfizer Company" which was issued in 2017.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/meridian-medical-technologies-inc-pfizer-company-525881-09052017
From the letter:
Drug CGMP Violations
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Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21CFR211.192).1
Among other things, you manufacture two epinephrine auto-injectors at your facility, EpiPen and EpiPen Jr., (collectively, EpiPen products). These products are intended to deliver a lifesaving drug (epinephrine) during emergency treatment of serious allergic reactions, including anaphylaxis. If your auto-injectors do not operate as expected and deliver the intended amount of epinephrine drug when deployed in emergencies, patients can die or suffer serious illness. You failed to thoroughly investigate multiple serious component and product failures for your EpiPen products, including failures associated with patient deaths and severe illness. You also failed to expand the scope of your investigations into these serious and life-threatening failures or take appropriate corrective actions, until FDA's inspection.
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In fact, your own data show that you received hundreds of complaints that your EpiPen products failed to operate during life-threatening emergencies, including some situations in which patients subsequently died.
Pfizer manufactures Epipen??? Fuggers.