Univar Solutions USA Inc. – FDA EIR, Dec 20, 2012

An FDA inspection of Univar USA, Inc. in Dallas, TX, was conducted from December 19-20, 2012. This routine, abbreviated inspection, conducted under CP 7356.002 (Drug Manufacturing Inspections) and 7303.803 (Domestic Food Safety Program), evaluated the firm's operations as a repacker and distributor of drug and food-grade chemicals. The scope included repacking, complaint handling, training, storage, cleaning validation, sampling, and batch records, focusing on Quality, Materials, and Production systems. While no FDA 483 was issued, three critical items were discussed. Firstly, the sampling method for repacked products was found not to be representative of the entire lot. Secondly, the firm had not revalidated cleaning procedures for dedicated hoses and lances introduced for product transfer, despite procedural changes. Thirdly, the quality manual lacked specific definition regarding who holds the responsibility for approving or rejecting repacked products for distribution. Univar USA committed to address these issues by performing necessary sampling and cleaning validations, and by amending their quality manual and Standard Operating Procedures to clearly outline responsibilities.