Drug factory · FDA FEI 3002806297
ACS Dobfar SPA
Viale Addetta 2a/12-3/5, Tribiano (MI), Italy
Problems found, fixed voluntarily at FDA's last inspection, May 16, 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 2010: 1 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Cefoxitin | Makes it | Samson Medical Technologies, L.L.C. | 66288-4100 |
| Ceftriaxone | Makes it | Samson Medical Technologies, L.L.C. | 66288-6100 |
| Meropenem and Vaborbactam | Makes the active ingredient, tests it and packages it | Melinta Therapeutics, LLC | 70842-120 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 16, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Dec 3, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 1, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 20, 2015 | No problems found | Drug Quality Assurance | — |
| Jul 4, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 10, 2010 | 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 16, 2023 inspection
- Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which monitor the output of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. - Validation lacking for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process. - Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
Registered with FDA for: analysis; api manufacture; manufacture; pack.