Cooper Institute — FDA Warning Letter Findings

Failure of a responsible person to determine and document the eligibility of a donor of reproductive cells or tissue based on the results of donor screening and testing [21 CFR 1271.50(a)]. For example, the records for the following anonymous oocyte donors did not contain documentation of the donor eligibility determination, including the name of the responsible person who made the determination, the date of the determination, and documentation that the donor was determined “eligible:” a. Oocytes were recovered from anonymous donor (b)(6) on June 28, 2021. b. Oocytes were recovered from anonymous donor (b)(6) on April 19, 2021. c. Oocytes were recovered from anonymous donor (b)(6) on February 6, 2021. d. Oocytes were recovered from anonymous donor (b)(6) on November 28, 2020. e. Oocytes were recovered from anonymous donor (b)(6) on July 14, 2020. f. Oocytes were recovered from anonymous donor (b)(6) on March 18, 2020.

Failure to establish and maintain procedures for all steps performed in testing, screening, and determining eligibility, and complying with all other requirements of Subpart C “Donor Eligibility” in 21 CFR Part 1271.45-1271.90. “Establish and maintain” means define, document (in writing or electronically), and implement; then follow, review, and as needed, revise on an ongoing basis [21 CFR 1271.47(a)]. Your firm does not have procedures for all steps that you perform in…

Failure to test a specimen from an anonymous or directed reproductive donor of cells or tissue, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents of the genitourinary tract. The reproductive cells or tissue were not recovered by a method that ensured freedom from contamination of the cells or tissue by infectious disease organisms that may be present in the genitourinary tract [21 CFR 1271.85(c)]. For example, there is no record that anonymous oocyte donor (b)(6) was tested for Chlamydia trachomatis and Neisseria gonorrhea at the time of oocyte recovery.

Failure to test a specimen from an anonymous or directed reproductive donor of cells or tissue, whether viable or non-viable, for evidence of infection due to relevant communicable disease agents [21 CFR 1271.85(a)]. For example: a. Living HCT/P donors should be tested for West Nile Virus (WNV) using an FDA-licensed Nucleic Acid Test (NAT) donor screening test for HCT/Ps recovered between June 1st and October 31st every year. Two anonymous oocyte donors ( (b)(6) ) were not tested for WNV during that time period. b. The donor specimen collected from anonymous oocyte donor (b)(6) on July 8, 2020, was not tested for human immunodeficiency virus, types 1 and 2 (HIV-1/2), hepatitis B virus (HBV), hepatitis C virus (HCV), and Treponema pallidum at the time of recovery on July 14, 2020.

Failure to screen a donor of reproductive cells or tissue by reviewing the donor’s relevant medical records for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases [21 CFR 1271.75(a)]. Under 21 CFR 1271.75(a), you must screen a donor of cells or tissue by reviewing the donor’s “relevant medical records” for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases. 21 CFR 1271.3(s) defines the term…