Drug factory · FDA FEI 3003468553
Derivados Quimicos SAU
Camino de Pliego, 150, Alcantarilla, Spain
Problems found, fixed voluntarily at FDA's last inspection, Feb 2, 2023.
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 2012: 0 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Levoketoconazole | Makes the active ingredient and tests it | Xeris Pharmaceuticals, Inc. | 72065-003 |
| Meloxicam and Rizatriptan | Makes the active ingredient | Axsome Therapeutics, Inc. | 81968-020 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 2, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 14, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 23, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Nov 15, 2012 | 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.
Oct 23, 2015 inspection
- Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Registered with FDA for: analysis; api manufacture.