FDA 483 - Jazz Pharmaceuticals, Inc - May 06, 2011

This FDA Form 483 was issued to Jazz Pharmaceuticals, Inc., a sponsor establishment located at 3180 Porter Dr, Palo Alto, CA, following an inspection from April 27, 2011, to May 6, 2011. The inspection identified three observations related to adverse drug experience reporting and procedures.

Observation 1 states that not all serious and unexpected adverse drug experiences were reported to the FDA within 15 calendar days. Specifically, 74 confirmed death reports for the drug product Xyrem, received and retained by the firm's specialty pharmacy between November 2002 and April 2011, were not expeditiously reported, with some being more than 2000 days late. These reports were previously undetected through the firm's monitoring of its specialty pharmacy.

Observation 2 indicates that written procedures for the surveillance, receipt, evaluation, and reporting of post-marketing adverse drug experiences to the FDA were not developed. This includes a lack of approved procedures for: verifying and monitoring third-party CROs and specialty pharmacies for adverse event data; determining if an event is serious or expected/unexpected; extracting and entering information into the electronic drug safety database; documenting and reporting follow-up information; preparing periodic safety reports; and documenting job-related employee training for drug safety and pharmacovigilance activities. This deficiency was highlighted by the 74 undetected death reports held by the specialty