Emmaus receives ‘No Action Indicated’ inspection classification from FDA

Emmaus Life Sciences announced receiving the “No Action Indicated” classification following a routine inspection by the United States Food and Drug Administration of Emmaus’ Postmarketing Adverse Drug Experience compliance program. The PADE program aims to shield patients from poor quality, unsafe, and ineffective dugs through proactive compliance strategies and risk-based enforcement actions. A major objective of the PADE program is to ensure that accurate, reliable, and timely safety data are submitted to the FDA in compliance with postmarking laws and regulations. The two and a half-day inspection by two FDA Consumer Safety Officers found no objectional condition or practice in the six years that Endari has been marketed and thereby received a “No Action Indicated” inspection classification.