Drug factory · FDA FEI 3002807108
Sanofi S.r.l.
Via Valcanello, 4, Anagni, Italy
Problems found, fixed voluntarily at FDA's last inspection, Oct 29, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
7 drug inspections on record since 2012: 0 with no problems, 7 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Acetylcholine | Makes it and packages it | Bausch & Lomb Incorporated | 24208-539 |
| Ferric Cation | Makes it, tests it, packages it and labels it | Sanofi-Aventis U.S. LLC | 0024-2792, 0024-2794 |
| Imiglucerase | Makes it, tests it, packages it and labels it | Genzyme Corporation | 58468-4663 |
| Insulin Glargine | Makes it, tests it, packages it and labels it | sanofi-aventis U.S. LLC | 0088-2220, 0088-5021 |
| Rasburicase | Makes it, tests it, packages it and labels it | Sanofi-Aventis U.S. LLC | 0024-5150, 0024-5151 |
| Rifampin | Makes it, tests it, packages it and labels it | Sanofi-Aventis U.S. LLC | 0068-0597, 0068-0599, 0068-0660 |
| Rifapentine | Makes it, tests it, packages it and labels it | sanofi-aventis U.S. LLC | 0088-2102 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 29, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 18, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 15, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 31, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jul 29, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 26, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 22, 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.
May 31, 2018 inspection
- Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed. - 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. - Sanitation--buildings not clean, free of infestation 21 CFR 211.56(a)
Buildings used in the manufacture, processing, packing or holding of drug products are not free of infestation by rodents, birds insects, and other vermin.
Registered with FDA for: analysis; label; manufacture; pack.