According to
Part 600 Subpart C, facilities are to be inspected at least every two years. The Food and Drug Administration (FDA) allows the Centers for Medicare and Medicaid Services (CMS), or an accrediting agency approved by CMS, to inspect where the facility is not required to register, i.e., a facility that does not manufacture blood components. However, all CFR regulations still apply, even if the FDA is not the inspecting agency. The inspectors look at records and interview personnel.
