Drug factory · FDA FEI 1000121235

Charles River Laboratories, Inc.

358 Technology Drive, Malvern, PA, United States

No problems found at FDA's last inspection, Jan 20, 2026.

No Action Indicated: inspectors found no objectionable conditions.

6 drug inspections on record since 2010: 5 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Daratumumab and Hyaluronidase (human Recombinant)	Tests it	Janssen Biotech, Inc.	57894-503
Imiglucerase	Tests it	Genzyme Corporation	58468-4663
Lunsotogene Parvec	Tests it	Regeneron Pharmaceuticals, Inc.	61755-062
Nirsevimab	Tests it	Sanofi Vaccines US Inc.	49281-574, 49281-575
Siltuximab	Tests it	Recordati Rare Diseases, Inc.	73090-420
Zopapogene Imadenovec	Tests it	Precigen, Inc.	84768-511

Ended	Result	Program	Problems noted
Jan 20, 2026	No problems found	Drug Quality Assurance	—
Jan 4, 2024	Problems found, fixed voluntarily	Drug Quality Assurance	2
Jan 17, 2019	No problems found	Drug Quality Assurance	—
Apr 20, 2015	No problems found	Drug Quality Assurance	—
Mar 15, 2012	No problems found	Drug Quality Assurance	—
Jan 8, 2010	No problems found	Drug Quality Assurance	—

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

Absence of Written Procedures 21 CFR 211.100(a)
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.

Registered with FDA for: analysis.