CFR section

21 CFR 1271.60(b): What quarantine and other requirements apply before the donor-eligibility determination is complete?

PART 1271-HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS · Subpart C-Donor Eligibility

Key facts

Citation 21 CFR 1271.60(b)
Section What quarantine and other requirements apply before the donor-eligibility determination is complete?
Part PART 1271-HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
Subpart Subpart C-Donor Eligibility
Subchapter 21 CFR L Other
Product types cited Other_Regulations
Regulation text (excerpt) (b) Identification of HCT/Ps in quarantine. You must clearly identify as quarantined an HCT/P that is in quarantine pending completion of a donor-eligibility determination. The quarantined HCT/P must be easily distinguishable from HCT/Ps that are available for release and distribution.

At a glance

  • 10–99 Inspections citing this section
  • 1–9 Warning letters citing this section

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About CFR sections cited by the FDA

Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.

Source: U.S. Code of Federal Regulations (eCFR); citation statistics from FDA inspection and warning-letter data

Browse all CFR sections cited by the FDA