Drug factory · FDA FEI 3001174929
Hospira Australia Pty Ltd
1-39 Lexia Pl, Mulgrave, Australia
Problems found, fixed voluntarily at FDA's last inspection, Sep 2, 2022.
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 2009: 3 with no problems, 2 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Aztreonam | Makes it, tests it, packages it and labels it | Hospira, Inc. | 0409-0829, 0409-0830 |
| Carboplatin | Makes it, tests it, packages it and labels it | Hospira, Inc. | 61703-150, 61703-262, 61703-339 +2 |
| Daptomycin | Makes it, tests it, packages it and labels it | Hospira, Inc. | 0409-0120, 0409-0122 |
| Methotrexate | Makes it, tests it, packages it and labels it | Hospira, Inc. | 61703-124, 61703-161, 61703-350 +1 |
| Paclitaxel | Makes it, tests it, packages it and labels it | Hospira, Inc. | 61703-015, 61703-342 |
| Pamidronic Acid | Makes it, tests it, packages it and labels it | Hospira, Inc. | 61703-324, 61703-325, 61703-326 |
| Topotecan | Makes it, tests it, packages it and labels it | Hospira, Inc. | 0409-0302 |
| Vincristine | Makes it, tests it, packages it and labels it | Hospira, Inc. | 61703-309 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 2, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 2, 2019 | No problems found | Drug Quality Assurance | — |
| Sep 15, 2015 | No problems found | Drug Quality Assurance | — |
| Mar 4, 2014 | Serious problems, FDA action | Drug Quality Assurance | 3 |
| Mar 21, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 25, 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.
Mar 4, 2014 inspection
- Following/documenting laboratory controls 21 CFR 211.160(a)
Established laboratory control mechanisms are not followed and documented at the time of performance. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and sampling plans designed to assure that in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity. - Extent of discrepancy, failure investigations 21 CFR 211.192
Investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product.
Registered with FDA for: analysis; label; manufacture; pack.