I usually try to Yogie (sleep 'til noon, but before it's dark); but today I woke up to work. A vendor got a 483 letter from the FDA today, and they want my magic wand.... **`:'(
RE: I'm blogging now, weeeee!
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I'm blogging now, weeeee!
is this in some kind of code? because I don't understand any of it. how can you sleep till noon but before it's dark when the sun rises at 7 AM?
and who knows what a 483 letter is? that's just bein mean to a redneck!
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You saw Yogi bear? He can sleep 'till noon, but before it's dark; he'll have every picnic basket that's in Jellystone park....
When Debbie stays up until 5AM; noon is about as good as it gets.
Sorry I was writing a response for the FDA, when I bloged this. A 483 letter is a "Bad Dog, fix this immediately" letter. It was wrong on so many points; it was not even legal! It is going to tax me, to deal with this level of stupidity! I have dealt with a lot of low quality FDA Inspectors, but this is the worst I have found, in three decades.
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lol! hey I haven't actually seen a cartoon about Yogi in probably 50 years so for some strange reason I don't remember the song!
the FDA thing though, what is that about?
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The FDA is a parasite that has no function! They accept funding from the very industries the are supposed to regulate. Their decisions are not medically sound, and they don't care about the end user, only their jobs! Thry are scum vermin, powered by bribes.
I get paid, well, to fight them. I usually win, because their inspectors are stupid, scum vermin. Just another job fighting them, and I plan to win!
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smithlabs.. well this is remarkable but in what capacity are you fighting them? are you a lawyer? and what are you fighting them ABOUT or over?
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I am fighting them with their own regulations. Lawyers are not allowed; it takes special approval, from the government; to sue the government! I fight them over GMP (Good Manufacturing Practices) as defined in CFR821. Their regulations; but they can be hung with their own paper! In the late 1980s, I got the BRH (Bureau of Radiologic Health) and the FDA (Food and Drug Administration) fighting because they were after Me, and reading things differently.
That is when I realized that their own paperwork was their greatest weakness! Been using it every since.
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lol! what a classic example of bloated, over-regulated bureaucracies who don't know their own regulations.
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A lot of their regulations are vague, deliberately! I get them to commit to their version, and then make them defend it, while using another version of the same regulation! Once they accept both variations, I get a pass!
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