Drug factory · FDA FEI 3006028606
Acs Dobfar Spa
Nucleo Industriale Sant'Atto, Teramo, Italy
Problems found, fixed voluntarily at FDA's last inspection, Dec 13, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2009: 1 with no problems, 6 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Cefotetan | Makes it and makes the active ingredient | Fresenius Kabi, LLC, Teligent Pharma, Inc. | 63323-385, 63323-386, 52565-052 +1 |
| Cilastatin and Imipenem | Makes it | Fresenius Kabi, LLC | 63323-322, 63323-349 |
| Ertapenem | Makes it | Fresenius Kabi, LLC, WG Critical Care, LLC. | 63323-823, 44567-820 |
| Meropenem | Makes it, tests it and packages it | Fresenius Kabi, LLC, Hikma Pharmaceuticals USA Inc. | 63323-507, 63323-508, 0143-9485 +1 |
| Meropenem and Vaborbactam | Makes it, tests it and packages it | Melinta Therapeutics, LLC | 70842-120 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 13, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 8, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 13, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 21, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 19, 2016 | Serious problems, FDA action | Drug Quality Assurance | 14 |
| May 23, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 27, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 6 |
| Oct 23, 2009 | 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.
Jan 19, 2016 inspection
- Following/documenting laboratory controls 21 CFR 211.160(a)
Established test procedures and laboratory control mechanisms are not followed. - Written records kept in individual logs 21 CFR 211.182
Written records of major equipment use are not included in individual equipment logs. - Written procedures followed 21 CFR 211.186(a)
Procedures for the preparation of master production and control records are not followed. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. - Complete test data included in records 21 CFR 211.194(a)
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. - Testing Calculations 21 CFR 211.194(a)(5)
Laboratory records are deficient in that they do not include all calculations performed during testing. - Test method modification records do not include 21 CFR 211.194(b)
Records maintained of any modification of an established method employed in testing do not include the reason for the modification and the data to verify that the modification produced results that are at least as accurate and reliable for the material being tested as the established method. - Authority lacking to review records, investigate errors 21 CFR 211.22(a)
The quality control unit lacks authority to fully investigate errors that have occurred. - Aseptic Processing Area 21 CFR 211.42(c)(10)
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products. - Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. - Cleaning System 21 CFR 211.42(c)(10)(v)
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions. - Equipment to control conditions 21 CFR 211.42(c)(10)(vi)
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions. - Buildings not maintained in good state of repair 21 CFR 211.58
Buildings used in the manufacturing of a drug product are not maintained in a good state of repair. - Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Mar 27, 2012 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. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that conform to appropriate standards of identity, strength, quality and purity. - Complete test data included in records 21 CFR 211.194(a)
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. - Sample identification and other information 21 CFR 211.194(a)(1)
Laboratory records do not include the date the sample was received for testing. - Adequate ventilation not provided 21 CFR 211.46(a)
Adequate ventilation is not provided. - Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Registered with FDA for: analysis; manufacture; pack.