Cryos International USA, LLC

FDA Regulatory Profile

Cryos International USA, LLC has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest inspection
Feb 28, 2025 · NAI

Reviewing Cryos International USA, LLC as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Cryos International USA, LLC yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections7Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 28, 2025Orlando, FLBiologicsNo Action Indicated (NAI)3011402904
Mar 22, 2024Raleigh, NCBiologicsVoluntary Action Indicated (VAI)3021830708
Jun 22, 2023Orlando, FLBiologicsNo Action Indicated (NAI)3011402904
Mar 8, 2022Orlando, FLBiologicsOfficial Action Indicated (OAI)3011402904
Apr 3, 2019Orlando, FLBiologicsNo Action Indicated (NAI)3011402904
Mar 14, 2017Orlando, FLBiologicsNo Action Indicated (NAI)3011402904
Jul 15, 2015Orlando, FLBiologicsVoluntary Action Indicated (VAI)3011402904

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3011402904Orlando, FL6Feb 28, 2025
FEI 3021830708Raleigh, NC1Mar 22, 2024

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.