CFR section
21 CFR 1271.55(d)(3): 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)(3) |
|---|---|
| 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) | (3) You must retain required records and make them available for authorized inspection by or upon request from FDA. Records that can be readily retrieved from another location by electronic means are considered “retained.” |
At a glance
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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.