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FDA Registration food facility - We operate under CGMP guidelines


Starting to get Involved
I'd like some feedback please: We are FDA registered as a Contract MFG, our facility manufactures class 1 medical products and subassemblies for various companies. Have a customer that now requires us to become registered as a 'food facility" due to their materials fall under the category of food. These ingredients are blended and converted in a medical product. We have manufactured this for over 5 years for this customer and they have now found out that the classification needs to be changed.
We operate under CGMP guidelines, are ISO13485 certified, manufacture 1 product that requires a microbiologist audit every other year and operate under "controlled' environment guidelines.
Other than going through the registration process and potential inspection from FDA, is there anything that we need to put in place prior to registration?
Thank you
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