Catalent Australia Pty Ltd
FDA Regulatory Profile
Catalent Australia Pty Ltd has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Nov 15, 2011 · NAI
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
| Nov 15, 2011 | Braeside, Australia | Food/Cosmetics | No Action Indicated (NAI) | 3004250913 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
| FEI 3004250913 | Braeside, Australia | 1 | Nov 15, 2011 |