Drug factory · FDA FEI 3003489017
Antibiotice SA
1 Valea Lupului Street, Iasi, Romania
Problems found, fixed voluntarily at FDA's last inspection, Sep 19, 2025.
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 |
|---|---|---|---|
| Ampicillin | Makes it | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-914, 23155-915, 23155-916 +1 |
| Ampicillin and Sulbactam | Makes it | Claris Lifesciences, Inc. | 36000-094, 36000-095 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 19, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 14, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 11, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 14, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| Jan 22, 2013 | No problems found | Drug Quality Assurance | — |
| Nov 9, 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.
Mar 14, 2017 inspection
- Test methods 21 CFR 211.165(e)
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed. - Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions. - 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 room and equipment to produce aseptic conditions.
Registered with FDA for: analysis; api manufacture; manufacture.