Drug factory · FDA FEI 3002807084
ACS Dobfar SpA
Via Alessandro Fleming 2, , Verona, Italy
Problems found, fixed voluntarily at FDA's last inspection, Oct 27, 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: 1 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Cefazolin | Makes it, tests it and packages it | Fresenius Kabi, LLC | 63323-236, 63323-237, 63323-238 +1 |
| Cefepime and Zidebactam | Makes it, tests it and packages it | Wockhardt Suisse USA LLC | 87706-866 |
| Cefotetan | Makes it, tests it and packages it | Fresenius Kabi, LLC | 63323-385, 63323-386 |
| Cefoxitin | Makes it, tests it and packages it | Fresenius Kabi, LLC | 63323-341, 63323-342 |
| Ceftriaxone | Makes it, tests it and packages it | Fresenius Kabi, LLC | 63323-345, 63323-346, 63323-347 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 27, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 19, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 19, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| May 20, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 18, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 8, 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.
Jun 19, 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 established, written and followed.
Registered with FDA for: analysis; manufacture; pack.