FDA WARNING_LETTER - Reproductive Technologies, Inc. - August 16, 2019

On November 6, 2019, the FDA issued a Warning Letter to Reproductive Technologies, Inc. following an inspection from August 5-16, 2019. The inspection revealed significant deviations from 21 CFR Part 1271 regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Key violations include: 1. **Failure to quarantine semen** from anonymous donors until required retesting was complete (21 CFR 1271.60(a)). Examples cited include semen distributed before the six-month retesting was performed. 2. **Failure to test anonymous semen donors for West Nile Virus (WNV)** using an FDA-licensed NAT donor screening test at the time of first donation within the June-October testing period, and/or failure to retest at least six months post-donation (21 CFR 1271.80 and 1271.85(d)). 3. **Failure to determine ineligible donors** with risk factors for communicable diseases (21 CFR 1271.75(d)(1)). Since March 2016, at least seven anonymous semen donors with a history of sex with other men in the preceding five years were deemed eligible. 4. **Failure to perform complete donor screening procedures** (21 CFR 1271.7