Drug factory · FDA FEI 3005164365
Bieffe Medital SA
Carretera Nacional 260, S/N, Sabinanigo (Senegue), Spain
Problems found, fixed voluntarily at FDA's last inspection, Apr 11, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2014: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Anhydrous Dextrose | Makes it, tests it, packages it, labels it and sterilizes it | Baxter Healthcare Corporation | 0338-0017, 0338-0062, 0338-0066 +8 |
| Bicarbonate Ion | Makes it, tests it, packages it, labels it and sterilizes it | Baxter Healthcare Corporation | 0338-0822 |
| Magnesium Cation | Makes it, tests it, packages it, labels it and sterilizes it | Baxter Healthcare Corporation | 0338-1708, 0338-1709, 0338-1715 +2 |
| Sodium Cation | Makes it, tests it, packages it, labels it and sterilizes it | Baxter Healthcare Corporation | 0338-0049, 0338-9543, 0338-9657 +3 |
| Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride and Magnes | Makes it, tests it, packages it, labels it and sterilizes it | Baxter Healthcare Corporation | 0338-9593 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 11, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 22, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 20, 2016 | No problems found | Drug Quality Assurance | — |
| Feb 23, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Feb 23, 2014 inspection
- Complete instructions, procedures, specifications et. al. 21 CFR 211.186(b)(9)
Master production and control records lack complete manufacturing and control instructions and specifications. - Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up. - 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. - Product flow through building is inadequate 21 CFR 211.42(b)
The flow of labeling, in-process materials, and drug products though the building is not designed to prevent contamination.
Registered with FDA for: analysis; label; manufacture; pack; sterilize.