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FDA Guidance for Industry: "Lookback" for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV

Internet:

https://www.gmp-compliance.org/files/guidemgr/Lookback for Hepatitis C Virus.pdf

Origin/Publisher:

Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/

Document Type:
Guidance for Industry DRAFT
Content:
This guidance document provides recommendations for complying with 21 CFR 610.47 and 21 CFR 610.48 to (1) blood establishments that collect blood or blood components, including Source Plasma and Source Leukocytes, (2) hospitals, and (3) other consignees referring HCV

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