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Thread: FDA Crackdown?

  1. #21
    soforene's Avatar
    soforene is offline The Troll formerly known as Herbert Von Poople-Futtocks
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    Quote Originally Posted by keeperx View Post
    well i think he should just call Dan and let him know whats up.. .
    He called Dan.
    Dan is not a nice man.

    Praise be to Allah that I don't live in the land of the free and the home of the brave (I always wondered whether they meant a red indian brave).

  2. #22
    mixedgas's Avatar
    mixedgas is offline Creaky Old Award Winning Bastard Technologist
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    Quote Originally Posted by keeperx View Post
    well i think he should just call Dan and let him know whats up.. see if he is actually doing something wrong and go from there.

    Have you ever in your life sat across the desk from a investigating officer?


    Ever Hear of Miranda V. Arizona...

    You have the right to remain silent. Anything you do or say may be used against you in a court of law........

    I know that is for arrest, but this fellow is "In hack" as the military says, and thus its perfectly applicable.
    His to call to Mr Hewitt was noted, logged, and transcribed, if not recorded.

    And I'd say its Mr Hewitt at this point.

    Mr Hewitt is doing as he is trained to do. Federal law enforcement types go to a school in Georgia, and they teach them how to act in these situations. Its a mix of strict and suspicious. Dan has also been taught how to sneek in leading questions. They never leave you off the hook until the investigating is done, the forms are signed, and they are out the door. They also don't smile until Christmas.

    If it wasn't a federal document and part of my records, I'd scan in a inspection form.

    It starts,and this is from memory so it may not be exact. "The Secretary of the Department of Health and Human services has determined.....blah blah blah, That a inspection of your premises may be done at any hour and any day without notice.... blah blah blah"

    Its the executive branch version of a warrant. When you did the manufacturers report,or entered into trade, you signed that warrant yourself.
    The inspecting officer makes a big deal of showing you his badge and his orders and his ID, and has you sign the form that you have seen them.

    Any Saturday or Sunday or when off duty and Dan is a regular Joe. Give him a break, besides lasers he is responsible to make sure your house lamps dont fry your corneas with UV and the CT scan you have next week doesn't cook your brain with X-rays.

    Steve
    Last edited by mixedgas; 05-07-2009 at 13:28.
    Qui habet Christos, habet Vitam!
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  3. #23
    mixedgas's Avatar
    mixedgas is offline Creaky Old Award Winning Bastard Technologist
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    Quote Originally Posted by soforene View Post
    He called Dan.
    Dan is not a nice man.

    Praise be to Allah that I don't live in the land of the free and the home of the brave (I always wondered whether they meant a red indian brave).

    The "brave" part refers to someone who being dumb enough or gallant enough, while under armed, under equipped, underfed, and under rotten circumstances, to walk up to one of your bloody Redcoats and tell him to get off our lawn.
    Actual bravery, or treason, depending on which side of the pond you were at the time.

    The irony is the star spangled banner is set to a old English drinking club song melody.

    Begin quote:
    To Anacreon in Heaven, where he sat in full glee,
    A few sons of harmony sent a petition,
    That he their inspirer and patron should be.
    When this answer arrived from that jolly old Grecian:
    Voice, fiddle and flute no longer be mute,
    I’ll lend you my name and inspire you to boot,
    And besides I’ll instruct you like me to entwine
    The myrtle of Venus with Bacchus’ vine."
    end quote
    Some guy named Tomlinson wrote that.

    Steve
    Qui habet Christos, habet Vitam!
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  4. #24
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    it is quite funny when i started to inform them on my thoughts on the letter and phone calls, a couple of real dim bulbs over there accused me of being Dan Hewett or a spy because my knowledge on the subject. Laughable,

    There are a several smart cookies over there but for the most part, sorry to say is guys who think they know whats going on...but really dont and they give other more clueless people BAD advice. The peter principle.
    Pat B

    laserman532 on ebay

    Been there, done that, got the t-shirt & selling it in a garage sale.

  5. #25
    mixedgas's Avatar
    mixedgas is offline Creaky Old Award Winning Bastard Technologist
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    Too bad we cant get their "frothychimp" guy to ome over here, since he just quit over there. Looks like another grad student or engineer who knows his stuff.

    Steve
    Qui habet Christos, habet Vitam!
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  6. #26
    soforene's Avatar
    soforene is offline The Troll formerly known as Herbert Von Poople-Futtocks
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    Quote Originally Posted by mixedgas View Post
    ... tell him to get off our lawn.
    Blimey !
    I never realised you wuz a Red Indian (or native American as they have somehow transmogrified into) cus surely they were the original custodians of America.
    Till the white man drove them off all the good land and into reservations.

    Damn you Paleskin and your promises of Shiny Beads and Whiskey !!

  7. #27
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    yep, hes top dog, a real good guy.
    Pat B

    laserman532 on ebay

    Been there, done that, got the t-shirt & selling it in a garage sale.

  8. #28
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    I am surprised that this didn't happen sooner. The website 'burning lasers' selling pointers must have been the straw that broke the fda's back.

    As for Pat trying to educate and give a little advice, the knuckle heads over there don't deserve it.
    They get sound advice from a pro and get bitchy. Screw 'em.

    Like Mixed said he needs to get legal representation and give Casey Stack a call and pray they don't decide to make an example of him.

    I wonder if some moron got popped with a hot pointer and gave him up?

    chad

    Pat: Pm him and invite him over here.


    When the going gets weird, the weird turn pro.


  9. #29
    mixedgas's Avatar
    mixedgas is offline Creaky Old Award Winning Bastard Technologist
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    Pat: Pm him and invite him over here.[/QUOTE]

    Yeah, and tell him about Casey and Laser Compliance Inc before his own lawyer does something stupid like challenge the FDAs jurisdiction or definitions. Since FDA is administrative law and not criminal, I'm sure there is not much in the way of case law and procedures on the books for a common lawyer more used to wills and drunk driving and probate.

    I doubt Casey will show any mercy, but this calls for a expert in CDRH remediation programs.

    Steve
    Qui habet Christos, habet Vitam!
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  10. #30
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    I was actually referring to "frothychimp" for the invite.
    I don't like to see any one railroaded, Casey would probably know best how to proceed in this. If nothing else it shows that he is taking it seriously and consulting with one of the best when it come to this stuff Casey is no stranger to the cdrh.

    Chad


    When the going gets weird, the weird turn pro.


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