# FDA 483 - Cryos International USA, LLC - March 08, 2022

Source: https://www.keypedia.com/records/483/cryos-international-usa-llc/0fe555bf-6645-4aa7-94c8-4f30c6a150ba

> FDA 483 for Cryos International USA, LLC on March 08, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cryos International USA, LLC
- Inspection Date: 2022-03-08
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Cryos International USA, LLC, a reproductive tissue establishment in Orlando, FL, was cited for multiple deficiencies related to donor screening and testing for communicable disease agents. Observations included failures in initial and retesting for diseases like West Nile Virus, inadequate donor screening questionnaires with incorrect timeframes and missing risk factors, and the use of abbreviated screening procedures. The firm also lacked comprehensive written procedures for HCT/P donor screening.

## Related Officers

- [Lura Baquero](https://www.keypedia.com/people/lura-baquero/55dc6eb5-01d5-427e-a3ef-cc6ca35f3837)

Company: https://www.keypedia.com/companies/cryos-international-usa-llc/48e2087d-09cd-49ad-b597-2f43bcce92ad

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6