Utah Cord Bank LLC
3 extracted findings
FDA source excerpt, selected passage
Failure to validate and approve a process according to established procedures where the results of processing cannot be fully verified by subsequent inspections and tests. The validation activities and results must be documented, including the date and signature of the individual(s) approving the validation [21 CFR 1271.230(a)]. 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 validate and approve a process according to established procedures where the results of processing cannot be fully verified by subsequent inspections and tests. The validation activities and results must be documented, including the date and signature of the individual(s) approving the validation [21 CFR 1271.230(a)]. For example:
Source passage selected by the model
02
Failure to establish and maintain procedures appropriate to meet core CGTP requirements for all steps that you perform in the manufacture of HCT/Ps. You must design these procedures to prevent circumstances that increase the risk of the introduction, transmission, or spread of communicable diseases through the use of HCT/Ps [21 CFR 1271.180(a)]. For example, you have not established and maintained procedures that include, but are not limited to the following:
Source passage selected by the model
03
Failure to maintain records concurrently with the performance of each step required in Subpart D and Subpart C of 21 CFR 1271. The records must identify the person performing the work and the dates of the various entries, and must be as detailed as necessary to provide a complete history of the work performed and to relate the records to the particular HCT/P involved [21 CFR 1271.270(a)]. For example, you have not maintained complete records that include, but are not limited to, the following:
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 1271.190(d)21 CFR 1271.22021 CFR 1271.230(a)21 CFR 1271.3(ff)21 CFR 1271.195(c)21 CFR 1271.180(a)21 CFR 1271.19521 CFR 1271.200(b)21 CFR 1271.21021 CFR 1271.25021 CFR 1271.26021 CFR 1271.26521 CFR 1271.270(a)21 CFR 1271.195(d)21 CFR 1271.200(e)21 CFR 1271.210(d)21 CFR 1271.260(e)21 CFR 1271.21521 CFR 1271.320(b)