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Birchwood Laboratories, Inc.

FDA Regulatory Profile

Birchwood Laboratories, Inc. has 0 FDA recalls, 10 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Feb 13, 2026 · VAI
Latest 510(k)
Sep 10, 1990

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances2Nov 8, 2026File dated Nov 2, 2026Current
Inspections10Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 13, 2026Eden Prairie, MNDrugsVoluntary Action Indicated (VAI)2182825
Jun 3, 2025Eden Prairie, MNDevicesNo Action Indicated (NAI)2182825
May 10, 2023Eden Prairie, MNDevicesNo Action Indicated (NAI)2182825
Aug 19, 2022Eden Prairie, MNDrugsVoluntary Action Indicated (VAI)2182825
Aug 18, 2017Eden Prairie, MNDevicesVoluntary Action Indicated (VAI)2182825
Oct 19, 2015Eden Prairie, MNDrugsNo Action Indicated (NAI)2182825
Jan 7, 2013Eden Prairie, MNDrugsVoluntary Action Indicated (VAI)2182825
Nov 4, 2011Eden Prairie, MNDrugsVoluntary Action Indicated (VAI)2182825
Apr 7, 2011Eden Prairie, MNDevicesNo Action Indicated (NAI)2182825
Feb 4, 2009Eden Prairie, MNDrugsNo Action Indicated (NAI)2182825

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 2182825Eden Prairie, MN10Feb 13, 2026

Recent 510(k) Clearances

K-NumberDeviceDate
K902589CYTOSET(TM)Sep 10, 1990
K902591CYTETTE(TM) CYTOLOGY BRUSHSep 10, 1990

FDA data resources

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