Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to determine as ineligible a donor who is identified as having a risk factor for, or clinical evidence of, any of the relevant communicable disease agents or diseases for which screening is required under 21 CFR 1271.75(a)(1) [21 CFR 1271.75 (d)(1)]. For example:
Passage 2Failure to include in the summary of records a statement noting the reason(s) for the determination of ineligibility in the case of an HCT/P from a donor who is ineligible based on screening and released under 21 CFR 1271.65(b) [21 CFR 1271.55(b)(4)]. For example:
Passage 3Failure to establish and maintain a standard operating procedure governing the release of an HCT/P from a donor whose specimen tests reactive for evidence of infection due to cytomegalovirus (CMV) [21 CFR 1271.85(b)(2)]. For example, your procedures do not include how the CMV test results will be communicated to the physician responsible for accepting the HCT/P so that they may rely on the information to make informed decisions about the use of an HCT/P in a particular recipient’s situation.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 1271
- 21 CFR 1271.65(b)(2)
- 21 CFR 1271.75(a)(1)
- 21 CFR 1271.85(b)(2)
- 21 CFR 1271.60(a)
- 21 CFR 1271.155
- 21 CFR 1271.75
- 21 CFR 1271.55(d)(1)(iii)
- 21 CFR 1271.55(b)(2)
- 21 CFR 1271.65(b)
- 21 CFR 1271.55(b)(4)
- 21 CFR 1271.45
- 21 CFR 1271.47(a)
- 21 CFR 1271.75(d)(1)
- 21 CFR 1271.80(d)(1)
- 21 CFR 1271.90(b)
- 21 CFR 1271.90(c)