Cryos International USA LLC

Warning LetterOpen

Corey A. Burke Tissue Bank Director Cryos International USA LLC 2200 N. Alafaya Trail, Suite 550 Orlando , FL 32826 United StatesFEI 3021830708Issued Oct 24, 2022Division of Biological Products Operations I

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3021830708.

Violations9

Issue DateOct 24, 2022

Product TypeBiologics

StatusOpen

Letter Details

Firm: Cryos International USA LLC
Location: Corey A. Burke Tissue Bank Director Cryos International USA LLC 2200 N. Alafaya Trail, Suite 550 Orlando , FL 32826 United States
FEI Number: 3021830708
Country: United States
Issue Date: October 24, 2022
Issuing Office: Division of Biological Products Operations I
Product Type: Biologics
Status: Open

Summary

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.

Cryos International USA LLC FDA Warning Letter, October 24, 2022