Drug factory · FDA FEI 1000514603

Regeneron Pharmaceuticals, Inc.

81 Columbia Turnpike, Rensselaer, NY, United States

Problems found, fixed voluntarily at FDA's last inspection, Mar 22, 2024.

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

10 drug inspections on record since 2010: 3 with no problems, 7 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Aflibercept	Makes it, makes the active ingredient and tests it	Regeneron Pharmaceuticals, Inc., Sanofi-Aventis U.S. LLC	61755-005, 61755-050, 61755-051 +2
Alirocumab	Makes the active ingredient and tests it	Regeneron Pharmaceuticals, Inc., Sanofi-Aventis U.S. LLC	61755-020, 61755-021, 0024-5901 +3
Atoltivimab and Maftivimab and Odesivimab	Makes the active ingredient and tests it	Regeneron Pharmaceuticals, Inc.	61755-018, 61755-019
Cemiplimab	Makes it, makes the active ingredient and tests it	Regeneron Pharmaceuticals, Inc.	61755-008
Dupilumab	Makes the active ingredient and tests it	Sanofi-Aventis U.S. LLC	0024-5914, 0024-5915, 0024-5918 +1
Garetosmab	Makes the active ingredient and tests it	Regeneron Pharmaceuticals, Inc.	61755-012
Linvoseltamab	Makes the active ingredient and tests it	Regeneron Pharmaceuticals, Inc.	61755-054, 61755-056
Lunsotogene Parvec	Makes the active ingredient and tests it	Regeneron Pharmaceuticals, Inc.	61755-062
Pozelimab	Makes the active ingredient and tests it	Regeneron Pharmaceuticals, Inc.	61755-014
Rilonacept	Makes the active ingredient and tests it	Kiniksa Pharmaceuticals (UK), Ltd.	73604-914
Sarilumab	Makes it, makes the active ingredient and tests it	Sanofi-Aventis U.S. LLC	0024-5908, 0024-5910, 0024-5920 +1

Ended	Result	Program	Problems noted
Mar 22, 2024	Problems found, fixed voluntarily	Drug Quality Assurance	—
Oct 25, 2021	Problems found, fixed voluntarily	Drug Quality Assurance	6
Oct 18, 2019	Problems found, fixed voluntarily	Drug Quality Assurance	1
Oct 5, 2017	No problems found	Drug Quality Assurance	—
Aug 19, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	1
Jun 13, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	1
May 24, 2013	Problems found, fixed voluntarily	Drug Quality Assurance	1
Jun 8, 2012	No problems found	Drug Quality Assurance	—
Jul 29, 2011	No problems found	Drug Quality Assurance	—
Mar 31, 2010	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 sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
Validation lacking for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
No written record of investigation 21 CFR 211.192
Written records are not always made of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications.
Cleaning System 21 CFR 211.42(c)(10)(v)
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the to produce aseptic conditions.
When to report 21 CFR 600.14(c)
Biological product deviations were not reported within the 45 calendar day timeframe.

Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.

Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.

Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

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