FDA 483 - Nexgen Pharma Inc - August 17, 2018

During an FDA inspection conducted from August 13-17, 2018, Nexgen Pharma Inc., a drug manufacturer located in Irvine, CA, was cited for multiple deficiencies related to post-marketing drug safety reporting and submission of regulatory documents. The observations, detailed in a Form FDA 483, indicate a lack of compliance with requirements under the Federal Food, Drug, and Cosmetic Act.

Key issues identified include the absence of adequate written procedures for the surveillance, evaluation, and reporting of post-marketing adverse drug experiences, specifically regarding 15-day alert reports from scientific literature and the preparation of Periodic Adverse Drug Experience Reports. The company also failed to submit required periodic reports containing comprehensive summaries, analyses of alert reports, and histories of actions taken due to adverse drug experiences. Instead, critical safety information was found to be incorrectly included in annual reports, leading to delayed or missing submissions for several drug products like Mecamylamine HCl tablets and various Butalbital combinations.

Furthermore, Nexgen Pharma Inc. did not submit several annual reports within the mandated 60-day timeframe following the anniversary of product application approval. The inspection also noted that individual case safety reports for non-serious adverse drug experiences were not consistently submitted in the required electronic format via the safety reporting portal.

The company is required to review these observations and implement appropriate corrective actions to ensure its post-marketing surveillance, reporting procedures, and regulatory submission timelines comply with FDA regulations to prevent future violations.