FDA Inspection 1234162 — Cryos International USA LLC

Cryos International USA LLC — FEI 3021830708

The FDA completed an inspection of Cryos International USA LLC on Mar 22, 2024 in Raleigh, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Mar 22, 2024
Fiscal Year
2024
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Raleigh, NC (United States)

Citations

IDCFRDescription
1225521 CFR 1271.60(c)Shipped but not kept in quarantine