Drug factory · FDA FEI 1196
Italfarmaco SPA
viale Fulvio Testi 330, Milan, Italy
Problems found, fixed voluntarily at FDA's last inspection, Jun 28, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2011: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Enoxaparin | Makes it | Italfarmaco S.p.A, Zydus Pharmaceuticals (USA) Inc. | 11797-757, 11797-758, 11797-759 +11 |
| Fondaparinux | Makes it, tests it, packages it and labels it | Italfarmaco S.p.A | 11797-154, 11797-155, 11797-156 +1 |
| Glatiramer | Makes it, tests it, packages it and labels it | Italfarmaco S.p.A, Zydus Pharmaceuticals (USA) Inc. | 11797-764, 11797-765, 70710-1548 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 28, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 1, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 18, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Mar 13, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Apr 11, 2014 | No problems found | Drug Quality Assurance | — |
| Oct 28, 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 18, 2018 inspection
- Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up. - 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.
Mar 13, 2015 inspection
- Stability sample storage conditions described 21 CFR 211.166(a)(2)
The written stability program for drug products does not describe the storage conditions for samples retained for testing. - Manufacturing Instructions and Specifications 21 CFR 211.186(b)(9)
The master production and control records are deficient in that they do not include complete instructions, procedures, special notations, and precautions.
Registered with FDA for: analysis; label; manufacture; pack.