Drug factory · FDA FEI 3002806559

Roche Diagnostics GmbH

Sandhofer Strasse 116, Mannheim, Germany

Problems found, fixed voluntarily at FDA's last inspection, Oct 29, 2021.

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 2009: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Atezolizumab	Makes it, tests it, packages it and labels it	Genentech, Inc.	50242-917, 50242-918
Atezolizumab and Hyaluronidase (human Recombinant)	Makes it, tests it and packages it	Genentech, Inc.	50242-933
Crovalimab	Makes it, tests it, packages it and labels it	Genentech, Inc.	50242-115
Glofitamab	Makes it, tests it, packages it and labels it	Genentech, Inc.	50242-125, 50242-127
Hyaluronidase (human Recombinant) and Ocrelizumab	Makes it, tests it and packages it	Genentech, Inc.	50242-554
Hyaluronidase (human Recombinant) and Pertuzumab and Trastuzumab	Makes it and tests it	Genentech, Inc.	50242-245, 50242-260
Hyaluronidase (human Recombinant) and Rituximab	Makes it, tests it, packages it and labels it	Genentech, Inc.	50242-108, 50242-109
Hyaluronidase (human Recombinant) and Trastuzumab	Tests it	Genentech, Inc.	50242-077
Methoxy Polyethylene Glycol-Epoetin Beta	Makes it and tests it	Vifor (International) Inc.	59353-400, 59353-401, 59353-402 +6
Mosunetuzumab	Tests it	Genentech, Inc.	50242-142, 50242-159, 50242-177 +1
Mycophenolic Acid	Makes it and tests it	Genentech, Inc.	0004-0259, 0004-0260, 0004-0261 +1
Obinutuzumab	Makes it, tests it and packages it	Genentech, Inc.	50242-070
Ocrelizumab	Makes it, tests it, packages it and labels it	Genentech, Inc.	50242-150
Peginterferon Alfa-2a	Tests it	pharmaand GmbH	82154-0449, 82154-0451
Pertuzumab	Makes it, tests it, packages it and labels it	Genentech, Inc.	50242-145
Polatuzumab Vedotin	Packages it and labels it	Genentech, Inc.	50242-103, 50242-105
Ranibizumab	Tests it	Genentech, Inc.	50242-078
Rituximab	Makes it, tests it, packages it and labels it	Genentech, Inc.	50242-051, 50242-053
Tocilizumab	Tests it, packages it and labels it	Genentech, Inc.	50242-135, 50242-136, 50242-137 +2
Trastuzumab	Tests it	Genentech, Inc.	50242-132
Trastuzumab Emtansine	Tests it	Genentech, Inc.	50242-087, 50242-088

FDA inspection history

Ended	Result	Program	Problems noted
Oct 29, 2021	Problems found, fixed voluntarily	Drug Quality Assurance	—
Apr 22, 2016	No problems found	Drug Quality Assurance	—
Apr 4, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	2
Apr 26, 2012	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jun 19, 2009	No problems found	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.

Apr 4, 2014 inspection

Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
Signatures and dates--person who performs test 21 CFR 211.194(a)(7)
Laboratory records do not include the initials or signature of the person who performs each test.

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