Bora Pharmaceuticals Injectables Inc

FDA Regulatory Profile

Bora Pharmaceuticals Injectables Inc has 0 FDA recalls, 15 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest inspection
Jul 25, 2024 · NAI

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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 9, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 25, 2024Baltimore, MDBiologicsNo Action Indicated (NAI)1000512361
Aug 10, 2023Baltimore, MDDrugsVoluntary Action Indicated (VAI)1000512361
Feb 18, 2022Baltimore, MDDrugsOfficial Action Indicated (OAI)1000512361
Apr 16, 2021Baltimore, MDDrugsVoluntary Action Indicated (VAI)1000512361
May 10, 2019Baltimore, MDDrugsNo Action Indicated (NAI)1000512361
Jun 13, 2018Baltimore, MDBiologicsVoluntary Action Indicated (VAI)1000512361
Dec 20, 2016Baltimore, MDDrugsVoluntary Action Indicated (VAI)1000512361
Aug 28, 2015Baltimore, MDDrugsVoluntary Action Indicated (VAI)1000512361
Aug 26, 2014Baltimore, MDDrugsVoluntary Action Indicated (VAI)1000512361
Apr 9, 2014Baltimore, MDDrugsVoluntary Action Indicated (VAI)1000512361
Aug 1, 2012Baltimore, MDDrugsVoluntary Action Indicated (VAI)1000512361
Jul 22, 2011Baltimore, MDBiologicsVoluntary Action Indicated (VAI)1000512361
Aug 27, 2010Baltimore, MDDevicesVoluntary Action Indicated (VAI)1000512361
Oct 20, 2009Baltimore, MDBiologicsVoluntary Action Indicated (VAI)1000512361
Aug 27, 2009Baltimore, MDDevicesNo Action Indicated (NAI)1000512361

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 1000512361Baltimore, MD15Jul 25, 2024

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