Drug factory · FDA FEI 3004468553

Patheon France S.A.S

40 Boulevard de Champaret, Bourgoin Jallieu, France

Problems found, fixed voluntarily at FDA's last inspection, Sep 29, 2023.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

5 drug inspections on record since 2014: 0 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Abiraterone	Makes it and tests it	Janssen Biotech, Inc.	57894-150, 57894-195
Abiraterone and Niraparib	Tests it	Janssen Biotech, Inc.	57894-050, 57894-100
Ferric Cation	Makes it, tests it, packages it and labels it	Shield TX (UK) Ltd	73059-001
Macitentan	Makes it, tests it, packages it and labels it	Actelion Pharmaceuticals US, Inc.	66215-501
Metoclopramide	Makes it, tests it, packages it and labels it	Evoke Pharma, Inc.	72089-307
Ponesimod	Makes it, tests it and packages it	Janssen Pharmaceuticals, Inc.	50458-720
Sorafenib	Makes it	Bayer HealthCare Pharmaceuticals Inc.	50419-488, 50419-489

Ended	Result	Program	Problems noted
Sep 29, 2023	Problems found, fixed voluntarily	Drug Quality Assurance	—
Sep 27, 2019	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jun 8, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	1
Mar 11, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	—
Mar 28, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	—

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Procedures for non-sterile drug products 21 CFR 211.113(a)
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established and written.

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