FDA Inspection 1238748 — Alphapharm Pty, Ltd.
The FDA completed an inspection of Alphapharm Pty, Ltd. on June 28, 2024 in Carole Park. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 28, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Carole Park (Australia)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |