Jazz Pharmaceuticals Operations UK Limited FDA Record
- Latest inspection VAI · Nov 13, 2020
- No warning letters matched by name
Jazz Pharmaceuticals Operations UK Limited has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Jazz Pharmaceuticals Operations UK Limited" is on file.
- Latest inspection
- Nov 13, 2020 · VAI
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 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Nov 13, 2020 | Sittingbourne, United Kingdom | Drugs | Voluntary Action Indicated (VAI) | 3004137922 |
- 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 3004137922 | Sittingbourne, United Kingdom | 1 | Nov 13, 2020 |
Jazz Pharmaceuticals Operations UK Limited and the FDA: common questions
Has Jazz Pharmaceuticals Operations UK Limited received an FDA warning letter?
No FDA warning letter addressed to the name "Jazz Pharmaceuticals Operations UK Limited" 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 Jazz Pharmaceuticals Operations UK Limited received an FDA Form 483?
FDA has not published a Form 483 for "Jazz Pharmaceuticals Operations UK Limited" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Jazz Pharmaceuticals Operations UK Limited?
The most recent FDA inspection on file ended Nov 13, 2020 at Sittingbourne, United Kingdom and was classified VAI. FDA has 1 inspection of Jazz Pharmaceuticals Operations UK Limited on file.
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