Each unit of Source Plasma shall be tested for evidence of infection due to relevant transfusion-transmitted infections as required under § 610.40 of this chapter .
21 CFR Part 640 · Additional Standards for Human Blood and Blood Products
§ 640.67 Laboratory tests
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
What FDA inspectors cite under § 640.67
Form FDA 483 observations citing this section, fiscal years 2011–2016 (Biologics).
- Laboratory tests 2
Amendment history
Federal Register documents that created or amended this section.
- 66 FR 31165 11 Jun 2001
- 80 FR 29905 22 May 2015