Company
United KingdomJazz Pharmaceuticals Operations UK Limited, Sittingbourne, United Kingdom – FDA Inspections
Inspection records and compliance data for Jazz Pharmaceuticals Operations UK Limited in Sittingbourne. 3 FDA inspections on record, 1 Form 483, last inspected September 25, 2026.
Company Profile
This profile covers Jazz Pharmaceuticals Operations UK Limited based in Sittingbourne, United Kingdom.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected March 6, 2018. Last inspected September 25, 2026.
Most cited issue areas
- Actual yield, % of theoretical yield1 inspection
- Component identification test1 inspection
- Investigations of discrepancies, failures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 25, 2026 | Not classified | Human Drugs · Drug Quality Assurance | 1338632 |
| November 13, 2020 | VAI | Human Drugs · Drug Quality Assurance | 1153380 |
| March 6, 2018 | Not classified | Human Drugs | 1046759 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Other regulators (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Jazz Pharmaceuticals Operations UK Limited
FEI Number
3004137922
Address
730 Building, Kent Science Park, Sittingbourne, United Kingdom
Country
United Kingdom
ID: 73701257-781b-43bb-a453-240dee8fae70