Drug factory · FDA FEI 3005468265
Baxter SA
Boulevard René Branquart 80 PO Box B1A, Lessines, Belgium
Problems found, fixed voluntarily at FDA's last inspection, Nov 17, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2019: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Leucine, Phenylalanine, Lysine Hydrochloride, Methionine, Isoleucine, Valine, Hi | Makes it, tests it, packages it, labels it and sterilizes it | Baxter Healthcare Corporation | 0338-0644 |
| Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threo | Makes it, tests it, packages it, labels it and sterilizes it | Baxter Healthcare Corporation | 0338-0180, 0338-0184, 0338-0188 +23 |
| Olive Oil and Soybean Oil | Makes it, tests it, packages it, labels it and sterilizes it | Baxter Healthcare Corporation | 0338-9540 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 17, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 27, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack; sterilize.