FDA 483 - Swabplus, L.P. - April 11, 2019

Genbplus, L.P. in Rancho Cucamonga, CA, a drug manufacturer, was cited for significant deficiencies across its operations, including inadequate laboratory controls, quality system failures, and issues with facilities and equipment. The inspection revealed a lack of proper component and finished product testing, unvalidated test methods, and insufficient data integrity controls. These findings indicate a broad failure to adhere to Good Manufacturing Practices.