Catalent Italy S.P.A. FDA Record
Catalent Italy S.P.A. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Catalent Italy S.P.A." is on file.
- Latest inspection
- Jan 25, 2017 · NAI
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jan 25, 2017 | Aprilia, Italy | Food/Cosmetics | No Action Indicated (NAI) | 3004273375 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3004273375 | Aprilia, Italy | 1 | Jan 25, 2017 |
Catalent Italy S.P.A. and the FDA: common questions
Has Catalent Italy S.P.A. received an FDA warning letter?
No FDA warning letter addressed to the name "Catalent Italy S.P.A." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Catalent Italy S.P.A. received an FDA Form 483?
FDA has not published a Form 483 for "Catalent Italy S.P.A." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Catalent Italy S.P.A.?
The most recent FDA inspection on file ended Jan 25, 2017 at Aprilia, Italy and was classified NAI. FDA has 1 inspection of Catalent Italy S.P.A. on file.
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