Drug factory · FDA FEI 3005884589
Rivopharm Sa
CENTRO INSEMA, Manno, Switzerland
No problems found at FDA's last inspection, Jun 23, 2023.
No Action Indicated: inspectors found no objectionable conditions.
4 drug inspections on record since 2014: 2 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Nitisinone | Makes it, tests it and packages it | Cycle Pharmaceuticals Ltd. | 70709-000, 70709-002, 70709-005 +1 |
| Tranylcypromine | Makes it | Solco Healthcare U.S., LLC | 43547-655 |
| Trimipramine | Makes it, tests it, packages it and labels it | Breckenridge Pharmaceutical, Inc. | 51991-944, 51991-945, 51991-946 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 23, 2023 | No problems found | Drug Quality Assurance | — |
| Jan 18, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Oct 30, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 3, 2014 | No problems found | 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.
Jan 18, 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.
Registered with FDA for: analysis; label; manufacture; pack.