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American CryoStem Corporation

FDA Regulatory Profile

American CryoStem Corporation has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest inspection
May 22, 2024 · OAI

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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
Inspections3Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
May 22, 2024Monmouth Junction, NJBiologicsOfficial Action Indicated (OAI)3008307548
Oct 8, 2019Monmouth Junction, NJBiologicsOfficial Action Indicated (OAI)3008307548
Jul 26, 2017Monmouth Junction, NJBiologicsOfficial Action Indicated (OAI)3008307548

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 3008307548Monmouth Junction, NJ3May 22, 2024

FDA data resources

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