FDA Inspection 1257835 — Mayne Pharma International PTY LTD
The FDA completed an inspection of Mayne Pharma International PTY LTD on Mar 21, 2025 in Salisbury South. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 21, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Salisbury South (Australia)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |