Bora Pharmaceuticals Laboratories, Inc

FDA Regulatory Profile

Bora Pharmaceuticals Laboratories, Inc has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 21, 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
Inspections7Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 21, 2025Miaoli County, TaiwanDrugsVoluntary Action Indicated (VAI)3007184570
May 24, 2019Miaoli County, TaiwanDrugsNo Action Indicated (NAI)3007184570
Feb 17, 2017Miaoli County, TaiwanDrugsNo Action Indicated (NAI)3007184570
Apr 15, 2016Miaoli County, TaiwanDrugsVoluntary Action Indicated (VAI)3007184570
Jul 26, 2014Miaoli County, TaiwanDrugsVoluntary Action Indicated (VAI)3007184570
Jul 26, 2012Miaoli County, TaiwanDrugsNo Action Indicated (NAI)3007184570
Jun 18, 2009Miaoli County, TaiwanDrugsVoluntary Action Indicated (VAI)3007184570

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 3007184570Miaoli County, Taiwan7Jul 21, 2025

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