FDA 483 - Nexgen Pharma Inc - August 17, 2018

Nexgen Pharma Inc. in Irvine, CA, was inspected and cited for significant deficiencies in its post-marketing adverse drug experience reporting system. Observations included a lack of adequate written procedures for adverse event surveillance and reporting, failure to submit complete periodic reports, and untimely submission of annual reports. Additionally, the firm did not submit all safety reports in the required electronic format.