Drug factory · FDA FEI 3005491771
Lusomedicamenta - Sociedade Tecnica Farmaceutica, S.a.
Estrada Consiglieri Pedroso, 69 B and 66, Queluz de Baixo, Portugal
Problems found, fixed voluntarily at FDA's last inspection, Oct 18, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2019: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Mebendazole | Makes it | Janssen Pharmaceuticals, Inc. | 50458-675 |
| Risperidone | Makes it, tests it, packages it and labels it | Janssen Pharmaceuticals, Inc. | 50458-305, 50458-596 |
| Rivaroxaban | Makes it | Janssen Pharmaceuticals, Inc. | 50458-578, 50458-579, 50458-580 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 18, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 27, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Sep 27, 2019 inspection
- Changes to Procedures Not Reviewed, Approved 21 CFR 211.100(a)
Changes to written procedures are not reviewed and approved by the quality control unit. - SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions. - Establishment of calibration procedures 21 CFR 211.160(b)(4)
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are deficiently written or followed. - Backup data not assured as exact and complete 21 CFR 211.68(b)
Backup data is not assured as secure from alteration, erasure or loss through keeping hard copy or alternate systems. - Top/Middle/Bottom container sampling 21 CFR 211.84(c)(4)
Sampling procedures are deficient regarding sampling components from the top, middle, and bottom of container.
Registered with FDA for: analysis; label; manufacture; pack; relabel; repack.