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Thread: FDA offical inspect our variance and accession number laser projector

  1. #1

    Laser Warning FDA offical inspect our variance and accession number laser projector

    FDA both offical visited our company and inspected our FDA approved laser projector last moth. We just need upgrade 2 points, one is add one interlock, only one interlock is not enough; another is that our remote box function is opposite, our original design is that the laser can work without connecting remote box, in order to let the user more convenient to operate the laser. Now it need be corrected.
    Others are no problem.
    Anybody have any doubt, pls just contact us ABLE laser.
    www.able-laser.com

  2. #2
    Join Date
    Aug 2009
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    Churchill(hour S from Houston)
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    That problem with the E-Stop set-up is the same with LaserKing PJs-

    Not sure my explaining the problem was undrestood--

    maybe if they see this..

    we can only hope
    BEYOND-FB3/APC40Mamba Black(clone & currently on loan) 2X 5paghetti & 2 I-Show 2X KGB 1000mW 532 DT40K (pair)XFX 1300 RGB full color RGB 30K DIY 3.5WRGB work in progress et al..assorted ttl chi-jectors--LOTS of LUMIA DIY pjs-
    Powered by Pangolin & ILDA Member

  3. #3
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    Apr 2009
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    Seattle, WA
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    Are you going to repair the lasers you have already sold to customers?

  4. #4

    Default

    Yes, we can correct and repair it

  5. #5
    Join Date
    Jan 2006
    Location
    Charleston, SC
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    2,147,488,269

    Exclamation

    Quote Originally Posted by ablelaser01 View Post
    Yes, we can correct and repair it
    Maybe there is a language barrier at work here, and if that's the case then I apologize. But Rick's question is very important.

    If the CDRH inspected your facility and told you that you needed to make those changes to be compliant, then that means you are obligated to make those changes on all the projectors you've sold under that product report. According to the FDA, it must be handled as a product recall, which means there is no cost to the customer.

    In other words, it's not a matter of "Yes, we CAN correct it", but rather, "Yes, we MUST correct it, and we WILL correct it immediately, on all the projectors we have sold."

    Adam

  6. #6
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    Apr 2009
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    Seattle, WA
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    Adam is 100% right there. It isn't an option, it is a requirement. The most professional way of handling a situation like this is to sent the clients new projectors so that they are not out of equipment while the lasers are being repaired.
    Quote Originally Posted by buffo View Post
    Maybe there is a language barrier at work here, and if that's the case then I apologize. But Rick's question is very important.

    If the CDRH inspected your facility and told you that you needed to make those changes to be compliant, then that means you are obligated to make those changes on all the projectors you've sold under that product report. According to the FDA, it must be handled as a product recall, which means there is no cost to the customer.

    In other words, it's not a matter of "Yes, we CAN correct it", but rather, "Yes, we MUST correct it, and we WILL correct it immediately, on all the projectors we have sold."

    Adam

  7. #7

    Default

    Quote Originally Posted by buffo View Post
    Maybe there is a language barrier at work here, and if that's the case then I apologize. But Rick's question is very important.

    If the CDRH inspected your facility and told you that you needed to make those changes to be compliant, then that means you are obligated to make those changes on all the projectors you've sold under that product report. According to the FDA, it must be handled as a product recall, which means there is no cost to the customer.

    In other words, it's not a matter of "Yes, we CAN correct it", but rather, "Yes, we MUST correct it, and we WILL correct it immediately, on all the projectors we have sold."

    Adam
    Your any question is welcomed. Don't need apologize, you are so kindly. Maybe I should explain more clearly. We can upgrade and repair the FDA standards laser you bought freely, If you can repair it by yourselves, we may send the spare parts to you freely, no any cost. If you can't, pls return the laser to us, we can upgrade it for you, the cost will be paid at our end. So anybody can contact us if you need our service

  8. #8

    Default

    Quote Originally Posted by buffo View Post
    Maybe there is a language barrier at work here, and if that's the case then I apologize. But Rick's question is very important.

    If the CDRH inspected your facility and told you that you needed to make those changes to be compliant, then that means you are obligated to make those changes on all the projectors you've sold under that product report. According to the FDA, it must be handled as a product recall, which means there is no cost to the customer.

    In other words, it's not a matter of "Yes, we CAN correct it", but rather, "Yes, we MUST correct it, and we WILL correct it immediately, on all the projectors we have sold."

    Adam
    Adam,that is language barrier,we are not English speaking country,we can't speak native English as you guys can ,we always translate Chinese meaning into English ,this is some misunderstand here .all we do is to meet requirement of FDA,so we must change it if we want sell good to USA

  9. #9
    Join Date
    Apr 2009
    Location
    Seattle, WA
    Posts
    646

    Default

    Here is the answer for people wanting to know if Entertainment was the member that got banned from able...
    Quote Originally Posted by entertainment View Post
    Adam,that is language barrier,we are not English speaking country,we can't speak native English as you guys can ,we always translate Chinese meaning into English ,this is some misunderstand here .all we do is to meet requirement of FDA,so we must change it if we want sell good to USA

  10. #10

    Default

    Quote Originally Posted by slicklasers View Post
    Here is the answer for people wanting to know if Entertainment was the member that got banned from able...
    we are in one company,it is normal

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