We have been operating our FFDM unit under FDA’s certification extension policy by linking our unit with a certified facility at a different location. Now that an accreditation body has been approved for our FFDM model unit, must we become accredited and certified as our own independent facility?
Yes. You need to become accredited and certified as your own independent facility. Once you have received your MQSA provisional certificate, you can sever your links with the other certified facility.