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Autocam Medical Devices, LLC

FDA Regulatory Profile

Autocam Medical Devices, LLC has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Oct 22, 2025 · VAI

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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 10, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Oct 22, 2025Plymouth, MADevicesVoluntary Action Indicated (VAI)3001644153
Aug 1, 2025Kentwood, MIDevicesVoluntary Action Indicated (VAI)3010047402
May 18, 2018Plymouth, MADevicesNo Action Indicated (NAI)3001644153

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 3001644153Plymouth, MA2Oct 22, 2025
FEI 3010047402Kentwood, MI1Aug 1, 2025

FDA data resources

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