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Drug factory · FDA FEI 3000264888
Patheon Inc.
2100 Syntex Court, Mississauga, Canada
Canada: 1
Problems found, fixed voluntarily at FDA's last inspection, Feb 24, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
7 drug inspections on record since 2011: 1 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
Drug Role For NDC
Abiraterone Makes it, tests it and packages it
Janssen Biotech, Inc. 57894-150 , 57894-195 Alosetron Makes it and tests it
Prometheus Laboratories Inc. , Sebela Pharmaceuticals Inc. 65483-894 , 65483-895 , 54766-894 +1Auranofin Makes it and tests it
Sebela Pharmaceuticals Inc. 54766-093 Bosentan Makes it
Actelion Pharmaceuticals US, Inc. 66215-232 Cabozantinib Makes it
Exelixis, Inc. 42388-023 , 42388-024 , 42388-025 Cobicistat and Darunavir Makes it and packages it
Janssen Products LP 59676-575 , 59676-577 , 59676-578 Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide Makes it and tests it
Janssen Products LP 59676-800 Dextromethorphan and Quinidine Makes it, packages it and labels it
Avanir Pharmaceuticals, Inc. 64597-301 Diazepam Makes it, tests it, packages it and labels it
Waylis Therapeutics LLC 80725-004 , 80725-005 , 80725-006 Ethinyl Estradiol and Levonorgestrel Makes it, tests it, packages it and labels it
Mayne Pharma Inc. 51862-028 , 51862-097 , 51862-545 Ethinyl Estradiol and Norethindrone Makes it, tests it and labels it
Millicent US, Inc. 72495-601 Ethinyl Estradiol and Norgestrel Makes it, tests it, packages it and labels it
Mayne Pharma Inc. 51862-564 Lenvatinib Makes it and tests it
Eisai Inc. 62856-704 , 62856-708 , 62856-710 +5Lonafarnib Makes it, tests it, packages it and labels it
Eiger BioPharmaceuticals, Inc. 73079-050 , 73079-075 Oteseconazole Tests it
Mycovia Pharmaceuticals, Inc. 74695-823 Oxcarbazepine Tests it
Ajanta Pharma USA Inc. 27241-304 , 27241-305 , 27241-306 Ponatinib Makes it, tests it, packages it and labels it
Takeda Pharmaceuticals America, Inc. 63020-533 , 63020-534 , 63020-535 +1Rilzabrutinib Makes it, tests it, packages it and labels it
Genzyme Corporation 58468-0251 Rivaroxaban Tests it and packages it
Janssen Pharmaceuticals, Inc. 50458-575 Sonidegib Makes it
Caraco Pharmaceutical Laboratories, Ltd. 47335-303 Tamsulosin Makes it, packages it and labels it
Sanofi-Aventis U.S. LLC 0024-5837
FDA inspection history
Ended Result Program Problems noted
Feb 24, 2023 Problems found, fixed voluntarily Drug Quality Assurance 1 Apr 12, 2019 Problems found, fixed voluntarily Drug Quality Assurance — Dec 2, 2016 No problems found Drug Quality Assurance — Nov 13, 2015 Problems found, fixed voluntarily Drug Quality Assurance — Jan 30, 2015 Problems found, fixed voluntarily Drug Quality Assurance — Apr 26, 2013 Problems found, fixed voluntarily Drug Quality Assurance — Feb 18, 2011 Problems found, fixed voluntarily Drug Quality Assurance —
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Feb 24, 2023 inspection
Written record of investigation incomplete 21 CFR 211.192 Registered with FDA for: analysis; label; manufacture; pack.
