Drug factory · FDA FEI 3002807359
Jetpharma SA
Via Sottobisio 42ac, Balerna, Switzerland
No problems found at FDA's last inspection, Jun 23, 2023.
No Action Indicated: inspectors found no objectionable conditions.
6 drug inspections on record since 2011: 3 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Bosentan | Mills it | Actelion Pharmaceuticals US, Inc. | 66215-101, 66215-102, 66215-232 |
| Macitentan | Mills it | Actelion Pharmaceuticals US, Inc. | 66215-501 |
| Macitentan and Tadalafil | Makes the active ingredient and mills it | Actelion Pharmaceuticals US, Inc. | 66215-812, 66215-814 |
| Maribavir | Mills it | Takeda Pharmaceuticals America, Inc. | 64764-800 |
| Ponesimod | Mills it | Janssen Pharmaceuticals, Inc. | 50458-707, 50458-720 |
| Tiratricol | Mills it | Rare Thyroid Therapeutics International AB | 87216-0100 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 23, 2023 | No problems found | Drug Quality Assurance | — |
| Feb 7, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Dec 1, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 29, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 8, 2013 | No problems found | Drug Quality Assurance | — |
| Feb 16, 2011 | 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.
Feb 7, 2020 inspection
- Storage under appropriate conditions 21 CFR 211.142(b)
Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected. - Complete Test Data 21 CFR 211.194(a)(4)
Laboratory records are deficient in that they do not include a complete record of all data obtained during testing. Electronic records are used, but they do not meet audit trail and authority check requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
Registered with FDA for: api manufacture; particle size reduction.