FDA 483 - Swabplus, L.P. - October 15, 2021

Swabplus, L.P. in Rancho Cucamonga, CA, a drug manufacturer, was cited for numerous deficiencies across its manufacturing and quality systems. The inspection revealed a lack of adequate procedures and controls for water systems, computer systems, equipment cleaning validation, test method validation, laboratory controls, supplier qualification, change management, and process validation. These issues indicate a broad failure to ensure the quality, purity, and strength of their drug products.