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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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Section Summary

Key Points
  1. The phone number and address of the FDA offices should be available to staff who must report adverse events and biological deviations.
  2. Annual reporting of the types of products manufactured is required for those facilities that manufacture blood components.
  3. The FDA has defined shipment temperatures: red cells below 10°C and frozen blood products must remain frozen.
  4. If the FDA does not inspect the facility because the facility does not manufacture blood components, the Centers for Medicare and Medicaid Services (CMS) or an agency deemed to have equivalent or higher standards may inspect in place of the FDA.