Drug factory · FDA FEI 3003716872
Delpharm Milano SRL
VIA SALVATORE CARNEVALE 1, Segrate, Italy
Problems found, fixed voluntarily at FDA's last inspection, Feb 18, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2011: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Aliskiren | Makes it and packages it | Noden Pharma USA, Inc. | 70839-150, 70839-300 |
| Elafibranor | Makes it, tests it and packages it | Ipsen Biopharmaceuticals, Inc. | 15054-0080 |
| Finerenone | Packages it and labels it | Bayer HealthCare Pharmaceuticals Inc. | 50419-540, 50419-541, 50419-542 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 18, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 12, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 25, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Sep 19, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 24, 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.
Sep 25, 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 fully followed.
Registered with FDA for: analysis; label; manufacture; pack.