The New Hope Center for Reproductive Medicine — FDA Warning Letter Findings

Question 28 asks about travel to an area with active Zika virus (ZIKV) transmission in the past 6 months, but should ask about residence in, or travel to, an area with an increased risk for ZIKV transmission.

Failure to establish and maintain procedures for acceptance activities, as required by 21 CFR 820.80(a). Specifically, a. Step (b)(4) of your firm’s untitled and uncontrolled work instruction for assembling and testing Champion Full Spectrum UV devices stated, “ (b)(4) .” The work instruction did not adequately describe the acceptance criteria that must be met. Moreover, you confirmed that test results were not documented. b. Prior to this inspection, your firm did not have a documented work instruction for EBOO Full Spectrum UV device acceptance activities.

Your procedure includes testing for ZIKV under the “Final Serology Testing” section. Please note that there are currently no available tests for ZIKV that are considered appropriate for preventing transmission of ZIKV through HCT/Ps.

Question 29 asks about sex with a male who has been diagnosed with ZIKV but should ask whether the donor has had sex with a person who has been diagnosed with ZIKV in the past 6 months. In response to Observations 1 through 5, you stated that you have re-screened donors who were not evaluated for all required RCDAD risk factors, updated Summary of Records forms, and marked as “ineligible” donors who were not tested in accordance with regulatory requirements. Please note that…

The form does not include a question that screens donors for testing positive or reactive for WNV infection using an FDA-licensed or investigational WNV NAT donor screening test in the preceding 120 days.

The procedure is still missing many of the requirements in Subpart C of 21 CFR 1271.Under 21 CFR 1271.47(a), you must establish and maintain procedures for all steps that you perform in testing, screening, determining donor eligibility, and complying with all other requirements of the subpart. Please note that if you still have oocytes and/or semen in storage from donors whose screening and/or testing was not completed in accordance with 21 CFR Part 1271, FDA considers the…

The form does not include a question regarding persons who have had a past diagnosis of clinical, symptomatic viral hepatitis after their 11th birthday, unless evidence from the time of illness documents that the hepatitis was identified as being caused by hepatitis A virus, Epstein-Barr virus (EBV), or cytomegalovirus (CMV).

Question 12 asks about a medical diagnosis of West Nile virus (WNV) infection but does not ask about a suspicion of WNV.