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The page below is a sample from the LabCE course Current Good Manufacturing Practices for Transfusion Services. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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Establishment Inspections

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, ie, a facility that does not manufacture blood components. However, all of the CFR regulations still apply, even if the FDA is not the inspecting agency. The inspectors look at records and interview personnel. The specific duties of the inspector are discussed in section 600.22.