FDA Inspection 1257835 — Mayne Pharma International PTY LTD
The FDA completed an inspection of Mayne Pharma International PTY LTD on March 21, 2025 in Salisbury South. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 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 |