Drug factory · FDA FEI 3006244497
Janssen-Cilag Manufacturing, LLC
State Road 933, KM 0.1, Mamey Ward, Gurabo, PR, United States
Problems found, fixed voluntarily at FDA's last inspection, Feb 11, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2009: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Esketamine | Makes it, tests it and packages it | Janssen Pharmaceuticals, Inc. | 50458-028 |
| Infliximab | Makes it and tests it | Janssen Biotech, Inc. | 57894-030, 57894-160 |
| Methylphenidate | Makes it and tests it | Janssen Pharmaceuticals, Inc. | 50458-585, 50458-586, 50458-587 +1 |
| Paliperidone | Makes it and tests it | Janssen Pharmaceuticals, Inc. | 50458-550, 50458-551, 50458-552 +5 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 11, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Nov 23, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 7, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 23, 2013 | No problems found | Drug Quality Assurance | — |
| Feb 18, 2011 | No problems found | Drug Quality Assurance | — |
| Dec 16, 2009 | Problems found, fixed voluntarily | 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.
Feb 11, 2026 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. - 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.
Registered with FDA for: analysis; manufacture; pack.