> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Significant HCT/P Deviations at Cryos International
- URL: https://www.fdaweb.com/significant-hct-p-deviations-at-cryos-international/
- Published: 2022-12-07T12:00:00.000Z
- Updated: 2026-09-14T18:08:52.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5153335

A 2/9-3/8 FDA inspection at Cryos International in Orlando, FL, identified significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products. A just-released 10/24 Warning Letter says specific violations were:

- failing to test a specimen from an anonymous semen donor for evidence of infection due to relevant communicable disease agents; and/or failing to retest anonymous semen donors at least six months after the date of semen donation; and/or failing to quarantine semen from anonymous donors until the required retesting is complete;
- failing to screen a donor of reproductive cells or tissue by reviewing the donor’s relevant medical records for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases;
- failing to perform a complete donor screening procedure on a donor by reviewing the donor’s relevant medical records; and
- failing to establish and maintain procedures for all steps performed in testing, screening, determining donor eligibility, and complying with all other donor eligibility regulatory requirements.

The letter says Cryos’ 3/22 response to the form FDA-483 presented to the company following the inspection was inadequate to address the agency’s concerns.

Cryos was told to respond with a list of specific actions it has taken or plans to take to correct the noted violations and prevent them or similar violations from occurring again, with documentation of the actions and a schedule for completing the corrections. The company also was told that due to the seriousness of the violations it should attend a Zoom regulatory meeting with agency officials to discuss the steps Cryos is taking to address the violations.