Drug factory · FDA FEI 3010479596

Samsung Biologics Co., Ltd.

300, Songdo bio-daero, Yeonsu-gu, Incheon, South Korea

Problems found, fixed voluntarily at FDA's last inspection, Sep 1, 2023.

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

3 drug inspections on record since 2018: 0 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Aflibercept	Tests it	CELLTRION USA, Inc.	72606-026
Amivantamab and Hyaluronidase (human Recombinant)	Makes the active ingredient and tests it	Janssen Biotech, Inc.	57894-510, 57894-514, 57894-515 +1
Anifrolumab	Makes the active ingredient and tests it	AstraZeneca Pharmaceuticals LP	0310-3080
Daratumumab	Makes the active ingredient and tests it	Janssen Biotech, Inc.	57894-502
Denosumab	Makes the active ingredient	Cordavis Limited	83457-012
Nirsevimab	Makes it, makes the active ingredient and tests it	Sanofi Vaccines US Inc.	49281-574, 49281-575
Perflutren	Makes it and tests it	Lantheus Medical Imaging, Inc.	11994-017
Rituximab	Makes the active ingredient and tests it	Pfizer Laboratories Div Pfizer Inc	0069-0238, 0069-0249
Tildrakizumab	Makes the active ingredient	Caraco Pharmaceutical Laboratories, Ltd.	47335-177
Ublituximab	Makes it and makes the active ingredient	TG Therapeutics, Inc.	73150-150

Ended	Result	Program	Problems noted
Sep 1, 2023	Problems found, fixed voluntarily	Drug Quality Assurance	—
Nov 1, 2019	Problems found, fixed voluntarily	Drug Quality Assurance	1
Jun 26, 2018	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.

Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
Deviations from written production and process control procedures are not recorded and justified.

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