FDA EIR - Concept Laboratories, Inc. - October 26, 2018

Bio-Concept Laboratories, Inc. underwent an FDA inspection from October 18 to October 26, 2018, in Salem, NH. This abbreviated inspection, conducted under the regulatory framework of Animal Drug Manufacturing and Drug Manufacturing Compliance Programs, reviewed the firm's contract laboratory services for human and animal drug products. While no formal FDA-483 "Inspectional Observations" was issued during this visit, the inspection highlighted three main issues with company management. Concerns were raised regarding the timeliness of investigation closures for quality events, the adequacy of an investigation into the stability sample inventory system (specifically, the lack of a comprehensive inventory audit), and incomplete documentation of High Performance Liquid Chromatography (HPLC) instrument runs in their usage logs, which violated written procedures. Management at Bio-Concept Laboratories acknowledged these issues and committed to evaluating them and implementing appropriate actions to address the concerns. Notably, the inspection also verified that the company had successfully implemented corrective actions for three observations identified during a previous FDA inspection in October 2016.