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FDA Compliance Program Guidance Manual Chapter 42 – Blood and Blood Products Inspection of Source Plasma Establishments, Brokers, Testing Laboratories, and Contractors - 7342.002

Origin/Publisher:

Division of Federal-State Relations (HFC-150), U.S. Food and Drug Administration, 5600 Fishers Lane, Room 12-07, Rockville, Maryland 20857

Document Type:
Guidance Manual
Content:
This Compliance Program covers Source Plasma, Source Leukocytes, and Therapeutic Exchange Plasma intended for further manufacture into injectable drug products (e.g. immune globulin, albumin) and noninjectable products (e.g. in-vitro devices such as blood bank reagents), which are biological products subject to the licensure provisions of Section 351 of the Public Health Service Act (PHS).

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