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Intuitive Surgical, Inc. Message Board

  • drvermin drvermin Jun 25, 2013 6:26 PM Flag

    FDA 483

    I just forwarded the link to the 483 the FDA issued to my wife. This is her business that she does everyday all day. I will get her opinion on it when she gets a chance to digest it. I will point out before she reads it that it is her and her company's opinion that the FDA NEVER leaves ANY inspection now without issuing a 483. In previous years they would inspect and in a few cases walk away with no findings. However, during the last 2+ years she knows of not one single company that has undergone a followup audit that did not receive a 483. The inspectors will literally stay for upwards of two weeks until they find something so they can issue some kind of 483 just to justify their existence.

    My own reading of the 483 shows it to be nothing out of the ordinary. Failure to report incidents on time, failure to have an SOP in place, retracting of a new use until (I assume) further documentation is in place, etc. I've personally seen and have heard about plenty of these kinds of 483 issues in the past and they are just the kind of stuff the FDA finds and cites a company for. Stay tuned. My wife will report back soon.

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    • Ok first quick comment from my wife was "they inspected them for 25 days and that is the best they could stick them with?" LOL Never, ever in all her 18+ years in medical devices has she seen a company get audited for 25 days over the course of 4 weeks. She has had the FDA on one of her clients for 2 weeks and the actual on site time was 9 days and they thought that was excessive. And that company is far, far bigger than ISRG was. Her immediate comment was that the FDA needed to find something and it took them an EXCESSIVE amount of time to find 4 measly observations. She is digging further into the actual observations and the regs behind them. It does no good to make a judgement about an FDA 583 unless you know the specific regs they are saying were not followed.

    • Wouldn't it be cool if we could send OSHA or some other regulatory agency to the FDA offices for random safety etc. inspections. Bet it wouldn't take 2 weeks to find something. :-)

    • Well, ISRG has been under a microscope lately so, like you said, I'm sure they had to find something.

      But anyhow, it sounds similar to health inspections for restaurants...I betcha ISRG would probably have still received an "A" rating if they scored it like that.

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