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Plasma

The regulations in Subpart D Plasma that apply (or may apply) to transfusion services are:

  • The final product. (1) The final product shall be inspected immediately after separation of the plasma and shall not be issued for transfusion if there is:
    • any abnormality in color or physical appearance, or
    • any indication of contamination.
  • With the exception of Platelet Rich Plasma and Liquid Plasma the final product shall be inspected for evidence of thawing or breakage at the time of issuance, however, the containers need not be stored in a manner that shows evidence of thawing if records of continuous monitoring of the storage temperature establish that the temperature remained at -18°C or colder. If continuous monitoring of the product is not available, the final product shall be stored in a manner that will show evidence of thawing and shall not be issued if there is any evidence of thawing.