Trividia Manufacturing Solutions, Inc. – FDA EIR, Aug 24, 2018

An FDA comprehensive drug process inspection of Trividia Manufacturing Solutions, Inc., located in Lancaster, NH, was conducted from August 20-24, 2018. This inspection, focused on the company's Over-The-Counter (OTC) drug products, was part of the OPQO Division I Work-plan for FY-18 under Compliance Program 7356.002. The primary violation documented on a Form FDA 483 was related to the inadequate calibration of instruments. Specifically, the initial qualification of stability chambers used for OTC drug products lacked a performance qualification, and the company failed to conduct requalification as per regulatory expectations (21 CFR 211.160(b)(4)). Beyond this formal observation, discussions with management highlighted additional concerns. These included the Quality Unit's failure to implement corrective and preventive action (CAPA) plans in several deviation and Out-of-Specification (OOS) investigations, particularly for recurring employee errors. Furthermore, issues were noted regarding delays in reviewing contract laboratory microbial analysis results for environmental monitoring and insufficient thoroughness in investigating environmental monitoring excursions. Trividia Manufacturing Solutions' management acknowledged all observations and concerns. They committed to providing a written response to the FDA within 15 business days addressing the Form FDA 483 finding and indicated they would address the other identified issues.