Drug factory · FDA FEI 3002806613

Bausch Health Companies Inc.

100 Life Sciences Pkwy, Steinbach, Canada

Canada: 1

No problems found at FDA's last inspection, May 19, 2023.

No Action Indicated: inspectors found no objectionable conditions.

6 drug inspections on record since 2009: 6 with no problems, 0 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
Bicarbonate Ion and OmeprazoleMakes it and packages it Santarus, Inc.. 68012-052, 68012-054, 68012-102 +1
BupropionMakes it Bausch Health US, LLC, Oceanside Pharmaceuticals. 0187-0730, 0187-0731, 0187-5810 +5
CarbidopaMakes it Bausch Health US, LLC, Oceanside Pharmaceuticals. 25010-711, 68682-200
Chlordiazepoxide and ClidiniumMakes it Bausch Health US, LLC 0187-4100
DiclofenacMakes it Oceanside Pharmaceuticals. 68682-103
DiltiazemMakes it and packages it Bausch Health US, LLC, Oceanside Pharmaceuticals., PuraCap Laboratories LLC dba Blu Pharmaceuticals 0187-0795, 0187-0796, 0187-0797 +37
EnalaprilatMakes it, packages it and labels it Bausch Health US, LLC, Oceanside Pharmaceuticals. 0187-0140, 0187-0141, 0187-0142 +5
Enalaprilat and HydrochlorothiazideMakes it Bausch Health US, LLC 0187-0146
Ethacrynic AcidMakes it and packages it Bausch Health US, LLC, Oceanside Pharmaceuticals. 25010-215, 68682-011
FlucytosineMakes it Bausch Health US, LLC 0187-3554, 0187-3555
Isosorbide DinitrateMakes it and packages it Oceanside Pharmaceuticals. 68682-192, 68682-193
LorazepamMakes it Bausch Health US, LLC 0187-0063, 0187-0064, 0187-0065
MesalamineMakes it Salix Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc. 65649-103, 0093-9224
MetforminMakes it Oceanside Pharmaceuticals., Santarus, Inc.. 68682-018, 68682-021, 68012-003 +1
MethylnaltrexoneMakes it Salix Pharmaceuticals, Inc. 65649-150
MetyrosineMakes it and packages it Bausch Health US, LLC, Oceanside Pharmaceuticals. 25010-305, 68682-310
NifedipineMakes it Oceanside Pharmaceuticals. 68682-105, 68682-106, 68682-107 +2
PrimidoneMakes it, packages it and labels it Bausch Health US, LLC 66490-690, 66490-691
RifaximinMakes it Salix Pharmaceuticals, Inc. 65649-301, 65649-303
TolcaponeMakes it and packages it Bausch Health US, LLC, Oceanside Pharmaceuticals. 0187-0938, 68682-938
TrientineMakes it Bausch Health US, LLC 0187-2120

FDA inspection history

EndedResultProgramProblems noted
May 19, 2023No problems foundDrug Quality Assurance—
May 18, 2018No problems foundDrug Quality Assurance—
Sep 9, 2016No problems foundDrug Quality Assurance—
May 30, 2014No problems foundDrug Quality Assurance—
Mar 1, 2012No problems foundDrug Quality Assurance—
Aug 7, 2009No problems foundDrug Quality Assurance—

Registered with FDA for: analysis; label; manufacture; pack.