CFR section
21 CFR 1271.55(d)(1): What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?
PART 1271-HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS · Subpart C-Donor Eligibility
Key facts
| Citation | 21 CFR 1271.55(d)(1) |
|---|---|
| Section | What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain? |
| 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) | (1) You must maintain documentation of: (i) Results and interpretation of all testing for relevant communicable disease agents in compliance with §§ 1271.80 and 1271.85, as well as the name and address of the testing laboratory or laboratories; (ii) Results and interpretation of all donor screening for communicable diseases in compliance with § 1271.75; and (iii) The donor-eligibility determination, including the name of the responsible person who made the determination and the date of the… |
At a glance
- 1–9 Inspections citing this section
- None 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.