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3004y Rc; Ao Food and Drug Administration Fda  Form

3004y Rc; Ao Food and Drug Administration Fda Form

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as soon as the FDA released the final rule for the qmr back in February the first question everybody asked was do we have to have ISO 1345 certification and the answer is no the FDA is not going to require it and in fact they're not going to accept ISO 1345 certifications in lie of an FDA inspection they are going to continue the mdap program and they require a copy of the mdap report in lie of performing FDA eirs or inspections with an inspection report so yes it's a great idea to get ISO 1345 certified that's an objective third party giving you valuation yes you're meeting the requirements but that won't be instead of FDA inspections you'll have to do empty sap if you want to avoid FDA inspections and they also go one step further to say that wouldn't be an suitable way of qualifying suppliers

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