Drug factory · FDA FEI 3002806388
Alphapharm Pty Ltd
15 Garnet St, Carole Park, Australia
Problems found, fixed voluntarily at FDA's last inspection, Jun 28, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2008: 4 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Clorazepic Acid | Makes it, tests it, packages it and labels it | Aurolife Pharma LLC | 13107-319, 13107-320, 13107-321 |
| Paroxetine | Makes it | New Horizon Rx Group, LLC | 58517-160 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 28, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| May 3, 2024 | No problems found | Bioresearch Monitoring | — |
| Oct 24, 2019 | No problems found | Drug Quality Assurance | — |
| Sep 15, 2017 | No problems found | Drug Quality Assurance | — |
| Jul 2, 2015 | No problems found | Drug Quality Assurance | — |
| Jul 18, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 17, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 30, 2008 | Problems found, fixed voluntarily | 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.
Jun 28, 2024 inspection
- Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
Deviations from written production and process control procedures are not justified. - Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Registered with FDA for: analysis; label; manufacture; pack.