Drug establishmentActive, Registered FY2026FDA warning letter on file
Janssen Vaccines Corp.
Janssen Vaccines Corp. is an FDA-registered drug establishment (FEI 3012637764) located in . The facility is active, registered for FY2026. FDA has issued 1 warning letter(s) to this facility.
FDA warning letter
A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.
Establishment record
Inspection history
FDA publishes only a subset of inspection records and Form 483s, so "None on file" is not a guarantee of a clean inspection history.
Questions
Is Janssen Vaccines Corp. registered with the FDA?
Yes. Janssen Vaccines Corp. is an FDA-registered drug establishment (FEI 3012637764) in . Its current registration status is Active, Registered FY2026.
Has Janssen Vaccines Corp. received an FDA warning letter?
Yes. FDA issued a warning letter to Janssen Vaccines Corp.; the most recent is dated Jul 18, 2025 (CGMP/Finished Pharmaceuticals/Adulterated).
What does Janssen Vaccines Corp. do?
Janssen Vaccines Corp.'s FDA-registered operations are: ANALYSIS; LABEL; MANUFACTURE; PACK.
Related facilities
Source: FDA public data · status as of 2026-06-01