FDA WARNING_LETTER - Jazz Pharmaceuticals, Inc - May 06, 2011

This FDA Warning Letter to Jazz Pharmaceuticals, Inc., dated October 11, 2011, resulted from an inspection conducted from April 27 to May 6, 2011. The inspection identified significant violations of Section 505(k) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 314.80, concerning postmarketing adverse drug experience reporting.

Key violations include: 1. **Failure to develop adequate written procedures for adverse drug experience (ADE) surveillance, receipt, evaluation, and reporting [21 C.F.R § 314.80(b)].** The firm lacked procedures to ensure ADEs were detected, identified, assessed, and reported, particularly from their contracted specialty pharmacy and call center, which acted as the sole distributor of Xyrem. There were no SOPs for monitoring the pharmacy's compliance or for evaluating ADEs against the U.S. package insert, ensuring accurate reporting to FDA Form 3500A, or investigating 15-day Alert reports. 2. **Failure to submit serious and unexpected ADE reports to FDA within 15 calendar days of initial receipt [21 C.F.R. § 314.80(c)(1)(i)].** The firm failed to submit 74 serious unexpected ADE reports for Xyrem between January