Utah Cord Bank LLC — FDA Warning Letter Findings

Failure to adequately monitor environmental conditions and provide proper conditions for operations, where environmental conditions could reasonably be expected to cause contamination or cross-contamination of HCT/Ps or equipment, or accidental exposure of HCT/Ps to communicable disease agents [21 CFR 1271.195(c)]. For example, the steps in processing HCT/Ps you described to the investigators during the inspection include exposing the unit of cord blood to the environment by draining the umbilical cord blood from the original collection bag into (b)(4) vials. These conditions could reasonably be expected to cause contamination or cross-contamination of the HCT/Ps, however, you do not monitor environmental conditions in the (b)(4) for the presence of microorganisms.

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…

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: a. You failed to validate your process, which cannot be fully verified, used in the manufacture of HCT/Ps to ensure that your process does not cause contamination or cross-contamination and prevents the introduction, transmission or spread of communicable disease through the use of the HCT/P. b. Processing is defined at 21 CFR 1271.3(ff) and includes testing for microorganisms. You failed to validate your microbiological testing, which cannot be fully verified, used in the manufacture of HCT/Ps to ensure that your process prevents the introduction, transmission or spread of communicable disease through the use of the HCT/P.

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: a. Facilities (i.e.: maintenance/repairs, cleaning, sanitation) [21 CFR 1271.190(d)]; b. Environmental control [21 CFR 1271.195]; c. Equipment (i.e.: maintenance, cleaning, calibration) [21 CFR 1271.200(b)]; d. Verification of supplies and reagents [21 CFR 1271.210]; e. Processing and processing controls [21 CFR 1271.220]; f. Labeling controls [21 CFR 1271.250]; g. Storage [21 CFR 1271.260]; and h. Receipt, predistribution shipment, and distribution, including release criteria and shipping conditions [21 CFR 1271.265].