Drug factory · FDA FEI 3003723076
Cambrex Profarmaco Milano SRL
VIA EUGENIO CURIEL 34, Paullo, Italy
No problems found at FDA's last inspection, Nov 11, 2022.
No Action Indicated: inspectors found no objectionable conditions.
7 drug inspections on record since 2009: 3 with no problems, 3 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Hydrochlorothiazide and Irbesartan | Makes the active ingredient and tests it | Sanofi-Aventis U.S. LLC | 0024-5855, 0024-5856 |
| Hydrochlorothiazide and Lisinopril | Makes the active ingredient | Ranbaxy Laboratories Inc. | 63304-536, 63304-537, 63304-538 |
| Hydrochlorothiazide and Quinaprilat | Makes the active ingredient | Ranbaxy Laboratories Inc. | 63304-161, 63304-162, 63304-163 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 11, 2022 | No problems found | Drug Quality Assurance | — |
| Oct 1, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 7, 2019 | No problems found | Drug Quality Assurance | — |
| May 19, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 6, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 25, 2011 | No problems found | Drug Quality Assurance | — |
| Mar 31, 2009 | Serious problems, FDA action | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.