Re: FDA (b)anality

Subject: Re: FDA (b)anality
From: Gene Kim-Eng <techwr -at- genek -dot- com>
To: Bill Swallow <techcommdood -at- gmail -dot- com>
Date: Mon, 9 Jan 2012 12:25:01 -0800

Government inspections and audits being what they are, it might be years
before anyone noticed, and then one morning their product recall would be
on CNN.

Gene Kim-Eng

On Mon, Jan 9, 2012 at 10:51 AM, Bill Swallow <techcommdood -at- gmail -dot- com>wrote:

> Isn't it your regulatory affairs guy's job to decide these things so
> your company is compliant with the industry and the laws surrounding
> it? If the FDA insists you use the statement, then you likely need to
> use it as-provided. Any changes would need to be approved by the FDA
> else they could find your company at fault.
>
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Follow-Ups:

References:
FDA (b)anality: From: Chris Morton
Re: FDA (b)anality: From: Bill Swallow

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