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PCI San Diego, Inc.

FDA Regulatory Profile

PCI San Diego, Inc. has 0 FDA recalls, 15 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
May 9, 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
Inspections15Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
May 9, 2025San Diego, CADrugsVoluntary Action Indicated (VAI)3004575449
Sep 20, 2023San Diego, CADrugsVoluntary Action Indicated (VAI)3004575449
May 25, 2021San Diego, CADrugsVoluntary Action Indicated (VAI)3004575449
Nov 22, 2019San Diego, CADrugsVoluntary Action Indicated (VAI)3004575449
Aug 7, 2019San Diego, CADrugsVoluntary Action Indicated (VAI)3004575449
Feb 7, 2019San Diego, CABiologicsVoluntary Action Indicated (VAI)3004575449
Jun 1, 2017San Diego, CABiologicsVoluntary Action Indicated (VAI)3004575449
Apr 6, 2017San Diego, CADrugsVoluntary Action Indicated (VAI)3004575449
Aug 6, 2015San Diego, CABiologicsVoluntary Action Indicated (VAI)3004575449
May 18, 2015San Diego, CADrugsVoluntary Action Indicated (VAI)3004575449
Nov 15, 2013San Diego, CADrugsNo Action Indicated (NAI)3004575449
Jun 11, 2013San Diego, CABiologicsVoluntary Action Indicated (VAI)3004575449
Jul 18, 2012San Diego, CADrugsNo Action Indicated (NAI)3004575449
Aug 1, 2011San Diego, CADrugsNo Action Indicated (NAI)3004575449
Oct 23, 2008San Diego, CADrugsNo Action Indicated (NAI)3004575449

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 3004575449San Diego, CA15May 9, 2025

FDA data resources

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