FDA Inspection
Jazz Pharmaceuticals Operations UK LimitedJazz Pharmaceuticals Operations UK Limited – FDA Inspection, Sep 25, 2026
Record Details
This FDA Inspection record concerns Jazz Pharmaceuticals Operations UK Limited, with an inspection on September 25, 2026, issued by the Office of Inspections and Investigations, covering human drugs.
- Inspection Date
- September 25, 2026
- Product Type
- Human Drugs
View Company Profile
ID · daa51600-52d0-48cb-b1b6-15c628128bc5
Inspection Facts
- Inspection number
- 1338632
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.188(b)(7)Actual yield, % of theoretical yield
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.84(d)(2)Component identification test
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Jazz Pharmaceuticals Operations UK Limited
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 13, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 6, 2018 | Not classified | Office of Inspections and Investigations |
Other documents for Jazz Pharmaceuticals Operations UK Limited
- FDA Inspection 1153380 - 2020-11-13
- FDA Inspection 1046759 - 2018-03-06
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.