- Delivery Method:
- VIA UNITED PARCEL SERVICE
Recipient NameEliott D. Spencer, Ph.D.
- Utah Cord Bank LLC
8675 S Sandy Parkway, Bldg. 110
Sandy, UT 84070
- Issuing Office:
- Office Biological Products Operations – Division 2
May 11, 2021
[Warning Letter #OBPO 21-614021]
Dear Dr. Spencer:
The United States Food and Drug Administration (FDA) conducted an inspection of your firm, Utah Cord Bank, LLC, located at 8675 S Sandy Parkway, Bldg. 110, Sandy, UT 84070 from February 1-11, 2021. During the inspection, an FDA Investigator documented significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps)1 set forth in Title 21, Code of Federal Regulations (CFR) Part 1271 [21 CFR 1271], and issued under the authority of Section 361 of the Public Health Service Act [42 U.S.C 264].
The deviations documented on the Form FDA-483, List of Inspectional Observations, were presented to and discussed with you at the conclusion of the inspection. These items of concern include, but are not limited to, the items discussed below. All items below pertain to HCT/Ps recovered from donors between May 25, 2005 and February 11, 2021. Following our review of the information collected during the inspection, we identified additional concerns that are also included below.
1. 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.
2. 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.
3. 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].
4. 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:
a. Facility cleaning and sanitation [21 CFR 1271.190(d)];
b. Environmental control and monitoring activities [21 CFR 1271.195(d)];
c. Equipment maintenance, cleaning, sanitizing, and calibration [21 CFR 1271.200(e)];
d. Receipt, verification, and lot number of each supply and/or reagent used in the manufacture of HCT/Ps [21 CFR 1271.210(d)];
e. Storage temperatures [21 CFR 1271.260(e)];
f. Recovery [21 CFR 1271.215];
g. Processing (including sterility testing) [21 CFR 1271.220]; and
h. Complaints [21 CFR 1271.320(b)].
Based on the information obtained during the inspection and stated in your FDA 483 correspondence, it is unclear whether your products are intended for autologous use only, or whether they are also intended for allogeneic use in a first-degree or second-degree blood relative. Please clarify all potential uses of your products. Donor-eligibility determination, Subpart – C of 21 CFR 1271, is based on donor screening and testing for relevant communicable disease agents and diseases (described in §1271.50) and is required for all donors used in HCT/Ps except as outlined under §1271.90.
The deviations identified above are not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure that your establishment is in compliance with all the applicable requirements of the federal regulations. You are responsible for reviewing your firm’s operations as a whole to ensure that you fully comply with the law.
We acknowledge receipt of your letters dated March 5, 2021 and April 16, 2021, in response to the Form FDA 483 issued to you on February 11, 2021. We have reviewed your responses in which you state that you have retained the services of a consultant. However, other than retaining the services of a consultant, your response is silent regarding specific corrective actions to address the violations outlined above.
You should take prompt action to correct the violations addressed in this letter and prevent their recurrence. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice.
We request that you respond in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. If you believe that your product is not in violation of the law, include your reasoning and any supporting information for our consideration. Additionally, include any documentation necessary to show that correction of any of the above-noted violations has been achieved. If you cannot complete all corrections within fifteen (15) working days, please explain the reason for your delay and time frame within which the remaining corrections will be completed.
Your response should be sent to the following address: Marc Jackson, U.S. Food & Drug Administration, Office of Biological Product Operations – Division 2, DFC – BLDG 20 – W 6th Ave & Kipling St., Denver, CO 80225, or emailed to Marc.Jackson@fda.hhs.gov. If you should have any questions, please contact Marc Jackson, Compliance Officer at (303) 236-3083 or via e-mail.
Program Division Director
Office Biological Products Operations – Division 2
1 This letter applies solely to products manufactured for autologous use or, depending on your response to FDA's request at the close of this letter, any products manufactured for allogeneic use in a first-degree or second-degree blood relative. Accordingly, references in this letter to HCT/Ps or "products" do not include products manufactured by your firm that are not for autologous use or allogeneic use in a first-degree or second-degree blood relative. FDA intends to communicate with Utah Cord Bank, LLC separately regarding these products.