FDA WARNING_LETTER - Cryos International USA LLC - March 08, 2022

The FDA issued a Warning Letter to Cryos International USA, LLC, following an inspection from February 9 to March 8, 2022, which revealed significant deviations from HCT/P regulations (21 CFR Part 1271).

Key violations include: 1. **Failure to test and quarantine anonymous semen donors:** The firm failed to test anonymous semen donors for relevant communicable disease agents, including West Nile Virus (WNV), at the required intervals (e.g., at first donation within the June-October period, or six months after donation). Semen was also released from quarantine before retesting was complete for WNV, Chlamydia trachomatis, Neisseria gonorrhea, Treponema pallidum, and CMV. 2. **Inadequate donor screening:** The firm's donor history questionnaires (FORM 08.05.01.01.21 and FORM 08.01.02.01.05) lacked questions to assess risk factors for various communicable diseases, including HIV, HBV, HCV, vaccinia virus, and Zika virus (ZIKV), as well as specific high-risk behaviors. 3. **Incomplete donor screening procedures:** Repeat anonymous semen donors were released from quarantine without a complete donor screening procedure having been performed within the preceding six months. 4. **Deficient procedures:** The firm's "Human Cellular and Tissue-