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

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

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Record Summary

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

Violation Codes

21 CFR 1271.47(a)

21 CFR 1271.75

21 CFR 1271.90(c)

21 CFR 1271.85

21 CFR 1271

21 CFR 1271.60(a)

21 CFR 1271.155

21 CFR 1271.90(b)

21 CFR 1271.3(t)

21 CFR 1271.85(d)

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Record Information

Company

Cryos International USA LLC

Inspection Date

March 8, 2022

Product Type

Biologics

Office

Division of Biological Products Operations I

People

ID: d4cca683-1601-4235-aaec-5545f0653d7d

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