Jazz Pharmaceuticals Plc
Overview
Jazz Pharmaceuticals Plc is a global biopharmaceutical company focused on developing and commercializing innovative medicines for serious diseases. The company is dedicated to using its extensive scientific expertise to bring new treatments to market, particularly in the fields of neuroscience and hematology/oncology.
Therapeutic areas
FDA compliance signals
10 FDA enforcement records linked to this company.
- 4832019-06-10
Failure to comply with REMS Elements to Assure Safe Use (ETASU) B
- 4832019-06-10
Late submission of 15-day report
- 4832019-06-10
Failure to maintain records
- 4832014-04-04
Submission of report follow-up
- 4832014-04-04
Failure to investigate serious, unexpected events
- 4832014-04-04
Late submission of 15-day report
- 4832014-04-04
Failure to develop written procedures
- warning_letter2012-09-18
FDA Warning Letter (drug product)
- warning_letter2011-10-12
FDA Warning Letter (drug product)
- warning_letter2010-07-06
FDA Warning Letter (drug product)
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