Wednesday, January 30, 2019

For fans of the Warning Letter of the Week

A longer article from Bloomberg Businessweek's Drew Armstrong on the state of the American generic pharmaceutical market, including some pretty hair-raising anecdotes: 
...three federal inspectors arrived at Mylan NV’s manufacturing plant in Morgantown, West Virginia, and flashed their credentials. A tipster had raised concerns there might be unscrupulous activity at the factory where the generic giant makes some of its top-selling drugs. So, with Mylan executives looking over their shoulders in a conference room, the inspectors from the U.S. Food and Drug Administration, dressed in button-down shirts and ties, began an intense two-week examination. 
The team of chemistry experts sifted through thousands of random files containing what appeared to be forbidden exploratory tests, which some drugmakers have used to prevent quality failures from coming to light. The inspectors suspected Mylan laboratory staff had recorded passing scores on drugs that originally fell short of U.S. quality standards.  
The files didn’t identify which drugs may have been involved in any exploratory tests. Instead they had obscure names like “lop” and “Medium”—and one that ended in LMFAO, a popular acronym for “Laughing My [Redacted] [Redacted]* Off.”
 Well, far be it from me to disallow QC chemists from having their fun.

*redactions to circumvent corporate firewalls re: language issues

2 comments:

  1. "fans of tWLotW": it me, as the millennials say.

    Also the QA director at my old job, who I used to forward these to.

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  2. I hope that conservative talk radio show hosts (aka Judas goats) who harp about over-regulation get the LMFAO lot of that drug. Maybe they will begin wearing MACA (Make America Compliant Again) hats.

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