Acs Dobfar Spa
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- Italy
- Registered address
- Nucleo Industriale Sant'Atto, Teramo, San Nicolo' A Tordino (TE) 64100, Italy (ITA)
- Operations here
- analysismanufacturepack
- FDA identifiers
- FEI 3006028606 · DUNS 439962157
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-12-13
- VAIDrug Quality Assurance2022-04-08
- VAIDrug Quality Assurance2018-04-13
- VAIDrug Quality Assurance2017-07-21
- OAIDrug Quality Assurance2016-01-19
- VAIDrug Quality Assurance2014-05-23
- VAIDrug Quality Assurance2012-03-27
- NAIDrug Quality Assurance2009-10-23
Drugs this plant is listed as making
6 distinct drugs across 9 products name this site in their FDA label.
- Cefotetan DisodiumFresenius Kabi USA, LLC
- ertapenemWG Critical Care, LLC
- Ertapenem SodiumFresenius Kabi USA, LLC
- Imipenem and Cilastatin SodiumFresenius Kabi USA, LLC
- MeropenemFresenius Kabi USA, LLC
- Meropenem-VaborbactamMelinta Therapeutics, LLC
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.