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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Source Plasma Establishments (Rev 4/01)

 

GUIDE TO INSPECTIONS OF SOURCE PLASMA ESTABLISHMENTS 

 

JUNE 1997

 

(APRIL 2001 - Editorial Revisions)

 

NOTE: This document is reference material for Investigators and other FDA personnel. The document does not bind FDA, and does not confer any rights, privileges, benefits, or immunities for or on any person(s). An alternative approach may be used if such an approach satisfies the requirements of the applicable statues, regulations, or both.

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