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Cryos International USA LLC, a biologics company specializing in human cells and tissues, failed to comply with federal regulations for human cell, tissue, and cellular products (HCT/Ps) during an FDA inspection conducted in February-March 2022. The company did not adequately test semen from anonymous donors for communicable diseases, including West Nile Virus (WNV), at required intervals and failed to retest donors at least six months after donation as mandated by 21 CFR 1271.85(d). Additionally, the company did not quarantine semen specimens from anonymous donors until retesting was complete, as required under 21 CFR 1271.60(a). These deviations represented significant breaches of donor screening and product quarantine requirements designed to prevent the transmission of infectious agents through tissue-based products.