Drug factory · FDA FEI 3011875665
Tulex Pharmaceuticals Inc
5 Cedar Brook Drive, Cranbury, NJ, United States
Problems found, fixed voluntarily at FDA's last inspection, Mar 24, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2017: 2 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Desmopressin | Makes it and tests it | Eton Pharmaceuticals, Inc. | 71863-123 |
| Hydrocortisone | Makes it, tests it, packages it and labels it | Eton Pharmaceuticals, Inc. | 71863-116 |
| Methylergonovine | Makes it, tests it, packages it and labels it | Volley Pharmaceuticals, LLC | 83400-100 |
| Oxybutynin | Makes it, tests it, packages it and labels it | TruPharma LLC. | 52817-260, 52817-261 |
| Prednisolone | Makes it, tests it, packages it and labels it | TruPharma LLC. | 52817-860 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 24, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Feb 29, 2024 | No problems found | Bioresearch Monitoring | — |
| Aug 14, 2020 | No problems found | Drug Quality Assurance | — |
| Nov 21, 2017 | 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.
Mar 24, 2025 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test procedures designed to assure that components, drug product containers, closures and 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; label; manufacture; pack.