Mark S. Denker, M.D., PA dba Palm Beach Fertility Center
3 extracted findings
FDA source excerpt, selected passage
Failure 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:
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
01
Failure 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:
Source passage selected by the model
02
Failure 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:
Source passage selected by the model
03
Failure 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.
Source passage selected by the model
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.
21 CFR 127121 CFR 1271.65(b)(2)21 CFR 1271.75(a)(1)21 CFR 1271.85(b)(2)21 CFR 1271.60(a)21 CFR 1271.15521 CFR 1271.7521 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 1271.4521 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)