Drug factory · FDA FEI 3002724726
Ansto
New Illawarra Road, Lucas Heights, Australia
No problems found at FDA's last inspection, Jun 24, 2022.
No Action Indicated: inspectors found no objectionable conditions.
3 drug inspections on record since 2009: 3 with no problems, 0 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Technetium Tc-99m Pertechnetate | Makes it | Lantheus Medical Imaging, Inc., Shine Spect USA, LLC | 11994-090, 11994-091, 87333-090 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 24, 2022 | No problems found | Drug Quality Assurance | — |
| Feb 4, 2016 | No problems found | Drug Quality Assurance | — |
| Aug 14, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack; relabel; repack.