Pharmaceutical Specialties, Inc.

FDA Regulatory Profile

Pharmaceutical Specialties, Inc. has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Aug 15, 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
Inspections5Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 15, 2025Rochester, MNDrugsVoluntary Action Indicated (VAI)2150117
May 3, 2019Rochester, MNDrugsVoluntary Action Indicated (VAI)2150117
Feb 26, 2014Rochester, MNDrugsNo Action Indicated (NAI)2150117
Apr 25, 2012Tampa, FLFood/CosmeticsVoluntary Action Indicated (VAI)3008513539
Feb 20, 2009Rochester, MNDrugsNo Action Indicated (NAI)2150117

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 2150117Rochester, MN4Aug 15, 2025
FEI 3008513539Tampa, FL1Apr 25, 2012

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