Drug factory · FDA FEI 3004090027
Mayne Pharma International Pty Ltd.
1538 Main North Road, Salisbury South, Australia
Problems found, fixed voluntarily at FDA's last inspection, Mar 21, 2025.
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: 1 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Carbidopa and Levodopa | Makes it | Dr. Reddy's Laboratories Inc. | 75907-020, 75907-021, 75907-022 |
| Diltiazem | Makes it, tests it, packages it and labels it | Mayne Pharma Inc. | 51862-328, 51862-329, 51862-330 |
| Doxycycline | Makes it, tests it, packages it and labels it | Mayne Pharma Inc. | 51862-559, 51862-560, 68308-710 +3 |
| Erythromycin | Makes it, tests it, packages it and labels it | Mayne Pharma Inc. | 68308-250 |
| Guanfacine | Tests it | Takeda Pharmaceuticals America, Inc. | 54092-513, 54092-515, 54092-517 +1 |
| Itraconazole | Makes it and tests it | Mayne Pharma Inc. | 51862-462 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 21, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Oct 18, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 15, 2017 | No problems found | Drug Quality Assurance | — |
| Sep 25, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 2, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 15, 2009 | 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.
Mar 21, 2025 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess. - Storage under appropriate conditions 21 CFR 211.142(b)
Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Registered with FDA for: analysis; label; manufacture; pack.