FDA Form MDSAP AU F0029.1.004 - Help with Completion

JoshuaFroud

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Hello All

I've finally received my dates from my AO regarding my MDSAP audit with stage 1 being at the end of January 2019 and stage 2 completed at the final facility in July 2019.

I have located and am now completing to return the form "MDSAP AU F0029.1.004" available on the following FDA MDSAP Audit Procedures and Forms directly from the FDA.

My question comes on the section on Addresses. We currently have two sites covered by our QMS certification that will both be being audited as part of MDSAP. The form in question only allows for one site or a "campus" but the guidance on the form is fairly clear on what a campus is and our two sites are not (about 2h30 drive apart).

Should I be submitting two forms? or has anyone else any experience with this? Thanks!

Further info, both sites have their own listing with the FDA but are run under the same QMS System
 
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