FDA EIR - Univar Solutions USA Inc. - March 17, 2017

A routine good manufacturing practice (cGMP) inspection was conducted at Univar USA, Inc. in Dallas, TX, from March 16-17, 2017. This review, performed under FDA guidelines for human drug repackers and relabelers, assessed the firm's operations for USP-grade products such as Glycerin, Isopropyl Alcohol 99%, and Propylene Glycol.

While no formal inspectional observations (FDA Form 483) were issued, two key issues were verbally discussed with management. Firstly, the facility exhibited inadequate pest protection due to a one-inch gap at a warehouse exit door where new product containers were stored. The company implemented a temporary fix and committed to a permanent door replacement. Secondly, Univar USA, Inc. had not established a defined storage condition for its USP Glycerin product. Records indicated that the monitored warehouse experienced temperatures exceeding 100°F multiple times. Management was instructed to define a specific temperature range for Glycerin storage and to establish procedures for evaluating any temperature deviations for their potential impact on product quality. Other operational systems, including quality, facilities, equipment, production, and packaging/labeling, were found to be compliant.