Drug factory · FDA FEI 1000440083
Baxter Healthcare Pty Ltd
1 Baxter Drive, Old Toongabbie, Australia
Problems found, fixed voluntarily at FDA's last inspection, Jul 5, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2022: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Heparin | Makes it, tests it, packages it, labels it and sterilizes it | Baxter Healthcare Corporation | 0338-0424, 0338-0428, 0338-0431 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 5, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jul 5, 2022 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 followed.
Registered with FDA for: analysis; label; manufacture; pack; sterilize.