Emmett F. Branigan, MD, PS, Inc – FDA Warning Letter, Jan 31, 2018

The FDA inspected Emmett F. Branigan, MD, PS, Inc. from January 29-31, 2018, identifying significant deviations from HCT/P regulations (21 CFR 1271). Key violations include:

1. **Failure to test for communicable disease agents (21 CFR 1271.85(a))**: An anonymous oocyte donor was deemed eligible without required Chlamydia, Neisseria gonorrhea, HIV-1/HBV/HCV, and WNV NAT testing. 2. **Failure to screen for relevant communicable disease agents (21 CFR 1271.75(a))**: * The "Donor Medical History Interview" form lacked questions to assess Zika virus risk, and multiple donors were not screened for ZIKV. * Relevant medical records ("Donor Physical Assessment Form," "Donor Physical Assessment Form (A)," and "Donor Medical History Interview") were incomplete for an oocyte donor before eligibility determination. 3. **Failure to determine and document donor eligibility (21 CFR 1271.50(a))**: A responsible person failed to sign the "Donor Eligibility Determination Form" for an oocyte donor. 4. **Failure to establish and maintain procedures for donor eligibility (21 CFR 1271.47(a))**: * The "Donor Medical