FDA 483 - Solvay USA Inc - November 13, 2015

Solvay USA Inc. in Spartanburg, SC, a non-sterile API manufacturer, received an FDA Form 483 with eight observations following an inspection from November 9-13, 2015. The observations primarily concern failures in quality control, including inadequate testing of raw materials and process water, insufficient computerized system controls, and deficiencies in stability testing, batch record documentation, quality agreements, and procedures for expired products. These issues indicate a lack of robust quality management systems for the firm's API product, IGEPAL CO-630 Special USP - Pharmaceutical Grade.