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Would the FDA audit my company?

Discussion in 'US Medical Device Regulations' started by Nikki, Aug 12, 2015.

  1. Nikki

    Nikki Well-Known Member

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    I work for a manufacturer who compounds plastic, which is pelletized.

    These compounds are sold to medical customers who use it to make medical devices. Mostly catheters.

    What are our chances of being audited by the FDA? We are not registered with the FDA at all. But I was told by another employee in Quality that he would guess that the FDA would want to audit us in the next few years.

    We have never been contacted by the FDA and we always conform to our customers regulatory requirements...

    Thanks in advance!

    -Nikki
     
  2. Ronen E

    Ronen E Well-Known Member

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    If something goes wrong with your clients' catheters and FDA concludes that it might be a raw material related issue, they might pay you a visit. I don't think it will be a full scale inspection, though.

    Other than that, you may not see them or hear from them for years.
     
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  3. QVarus

    QVarus New Member

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    Probably not. Last FDA audit we had, they told us they don't even have resources to audit any Class I device manufacturers.
     
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  4. Somashekar

    Somashekar Moderator Staff Member

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    You are compounding material that will be converted to a medical device which is invasive.
    You have a critical role in the health and safety of human.
    While I am sure your customer who will face FDA inspection is thorough in his regulatory requirements, You keep records and traceability to ensure that your compounding materials always meets your specification that your customer approved and then selected for making the catheters.
    If and when FDA comes, you can stand up with confidence to respond. Pay attention to whatever work environment you have determined such that it is maintained well.
     
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  5. Scott Kruger

    Scott Kruger Member

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    If you are not registered with the FDA it's not likely that they will inspect unless there is a problem that goes to the raw material you supply.
    They would leave that to your customers that are registered and make sure that they are maintaining proper supplier controls.
    I worked for a plastics molder for device and pharma and we were never inspected by either the drug or device folks so I really doubt the went to the level of our pellet suppliers.
     
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  6. Nikki

    Nikki Well-Known Member

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    Thank you all for the information. I was getting conflicting information from several people.
     
  7. Zara Joyce

    Zara Joyce Member

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    It depends on the FDA guidelines. If you are not violating those terms, they will not audit your company.
     

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