Re: We Design and Develop - All of our Manufacturing is Outsourced - ISO 13485 Questi
Hi,
Yes, it does sound bizarre, but it almost never actually happens because medical devices manufacturers who are subject to part 820 typically control their CMs one way or another. So, you don't have direct responsibility but some requirements may be "delegated" to you via your customer.
it's also been written here recently that the FDA doesn't "audit" per-se. the FDA holds inspections as it sees fit, and if you're not required to register you won't be on their "regular" inspection schedule. You might get inspected as part of an inspection held at your customer's (them being required to register) but then I guess you'd be inspected more as an extension of your customer's operations / QMS, rather than as an independent entity. If any deficiencies will be found, I guess the FDA will hold your customer accountable unless you acted fraudulently.
Cheers,
Ronen.
So, unless the contract says otherwise, we have no obligation to manufacture the device in accordance with the GMP or 21 CFR 820? That is the way I read the regulations, but that seems so bizarre to me that as the contract manufacturer we would not have some obligation or need to have the records necessary to pass an FDA audit, should it occur. Thanks for your input.
Hi,
Yes, it does sound bizarre, but it almost never actually happens because medical devices manufacturers who are subject to part 820 typically control their CMs one way or another. So, you don't have direct responsibility but some requirements may be "delegated" to you via your customer.
it's also been written here recently that the FDA doesn't "audit" per-se. the FDA holds inspections as it sees fit, and if you're not required to register you won't be on their "regular" inspection schedule. You might get inspected as part of an inspection held at your customer's (them being required to register) but then I guess you'd be inspected more as an extension of your customer's operations / QMS, rather than as an independent entity. If any deficiencies will be found, I guess the FDA will hold your customer accountable unless you acted fraudulently.
Cheers,
Ronen.