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Topic: legal aspects of laboratory testing  (Read 2717 times)

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Offline ken3009

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legal aspects of laboratory testing
« on: July 09, 2012, 05:21:11 AM »
so lets take a hypothetical situation, ill make it really simple:

Food company sends sample for gluten allergen testing to lab. Lab reports gluten test negative.

a person allergic to gluten eats a food from the company (same batch that was tested) and has severe reaction due to gluten which was present in the food, and lets say, dies (package states gluten free of course)

who is responsible here and who exactly pays the price? whats the nitty gritty of it. is it the actual lab technician, the lab company, or the food company who pays?

Offline Arkcon

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Re: legal aspects of laboratory testing
« Reply #1 on: July 09, 2012, 08:42:04 AM »
You're getting into the realm of FDA auditing.  Basically, there are occasional audits of laboratories, where an auditor -- either the FDA itself, or someone hired by the company, or someone who works for the company, does a review of documentation of recent procedures to be sure they are adequate to insure accidents like that don't happen.  It is more common to fail an audit, and get told you have to do a better job, than for an error to pass unnoticed.  Generally, it  isn't the bench analyst who is criminally responsible for serious failures.  Except in cases of blatant, outright, fraud:  for example, a procedure says you must adjust a reaction to pH 5, and you just don't, and never have, and don't care that it prevents the reaction from proceeding.  But that will more likely get you fired.  Failing to notice this shortcoming may get supervisors fired as well, but criminal prosecution is more reserved for supervisors who conspire to hide shortcomings like this.  But even the FDA rarely does this, the corporate culture has to be really sick for that to happen.
Hey, I'm not judging.  I just like to shoot straight.  I'm a man of science.

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