FDA EIR - Univar Solutions USA Inc. - January 08, 2014

A routine FDA surveillance inspection of Univar USA, Inc.'s Dallas, TX facility was conducted from January 5-8, 2014. The inspection, which focused on the company's operations as a repacker and relabeler of USP grade drug products like Isopropyl Alcohol, Glycerin, and Propylene Glycol, was carried out under regulatory frameworks for animal and human drug manufacturing inspections. Notably, the inspection concluded with no significant deviations observed, and no FDA Form 483 (Inspectional Observations) was issued, indicating a generally compliant operation. However, several important items were discussed with management at the inspection's conclusion. These included the necessity of developing written cleaning procedures for a newly installed stainless steel pipeline dedicated to Isopropanol USP. The company also lacked supporting documentation to confirm that customer-returned stainless steel totes, used for repacking Isopropanol USP, had been properly cleaned prior to refilling. Furthermore, the firm had not performed re-validation of cleaning procedures for product-specific hoses and lances, a point that had also been raised in the previous inspection. In response to these discussions, Univar USA, Inc. management committed to developing the required cleaning procedures for new equipment and working with their customer to establish documentation for container cleaning verification. The outstanding re-validation of cleaning procedures for existing equipment will also need to be addressed.