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Bausch Health Americas, Inc.

FDA Regulatory Profile

Bausch Health Americas, Inc. has 0 FDA recalls, 14 inspections, 1 510(k) clearance and 2 compliance actions on record.

Latest inspection
Sep 11, 2024 · NAI
Latest 510(k)
Oct 18, 2019

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances1Oct 4, 2026Not statedCurrent
Inspections14Oct 25, 2026Not statedCurrent
Compliance actions2Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 11, 2024Rochester, NYDevicesNo Action Indicated (NAI)3009443653
Apr 12, 2024Petaluma, CADrugsVoluntary Action Indicated (VAI)1000135370
Feb 2, 2018Rochester, NYDevicesNo Action Indicated (NAI)3009443653
May 10, 2017Rochester, NYDevicesNo Action Indicated (NAI)3009443653
Sep 1, 2016Rochester, NYDevicesOfficial Action Indicated (OAI)3009443653
Oct 26, 2015Petaluma, CADrugsNo Action Indicated (NAI)1000135370
Jul 28, 2015Rochester, NYDevicesOfficial Action Indicated (OAI)3009443653
Jun 26, 2014Rochester, NYDevicesOfficial Action Indicated (OAI)3009443653
Feb 28, 2013Petaluma, CADrugsNo Action Indicated (NAI)1000135370
Jan 23, 2013Petaluma, CADrugsNo Action Indicated (NAI)1000135370
Feb 10, 2012Petaluma, CADrugsNo Action Indicated (NAI)1000135370
Nov 4, 2010Petaluma, CADrugsNo Action Indicated (NAI)1000135370
Oct 8, 2010Petaluma, CADrugsNo Action Indicated (NAI)1000135370
Dec 10, 2009Petaluma, CADrugsNo Action Indicated (NAI)1000135370

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.

Recent 510(k) Clearances

K-NumberDeviceDate
K190342BIAFINE Topical CreamOct 18, 2019

FDA data resources