Hillestad Pharmaceuticals USA, Inc.

FDA Regulatory Profile

Hillestad Pharmaceuticals USA, Inc. has 0 FDA recalls, 13 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest inspection
Jun 27, 2025 · VAI

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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) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections13Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 27, 2025Woodruff, WIFood/CosmeticsVoluntary Action Indicated (VAI)2917045
Aug 23, 2022Woodruff, WIFood/CosmeticsNo Action Indicated (NAI)2917045
Jan 6, 2021Woodruff, WIFood/CosmeticsNo Action Indicated (NAI)2917045
Jun 20, 2019Woodruff, WIFood/CosmeticsVoluntary Action Indicated (VAI)2917045
Mar 2, 2018Woodruff, WIFood/CosmeticsVoluntary Action Indicated (VAI)2917045
Mar 3, 2017Woodruff, WIDrugsNo Action Indicated (NAI)2917045
Jul 1, 2016Woodruff, WIFood/CosmeticsVoluntary Action Indicated (VAI)2917045
Aug 20, 2014Woodruff, WIFood/CosmeticsVoluntary Action Indicated (VAI)2917045
Jul 18, 2013Woodruff, WIFood/CosmeticsVoluntary Action Indicated (VAI)2917045
May 27, 2012Woodruff, WIDrugsVoluntary Action Indicated (VAI)2917045
May 12, 2011Woodruff, WIFood/CosmeticsVoluntary Action Indicated (VAI)2917045
Jul 14, 2010Woodruff, WIDrugsNo Action Indicated (NAI)2917045
Jun 9, 2009Woodruff, WIFood/CosmeticsNo Action Indicated (NAI)2917045

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 2917045Woodruff, WI13Jun 27, 2025

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