FDA 483 - Domino Pads, LLC - August 21, 2019

An FDA inspection of Domino Pads, LLC, a medical device manufacturer in Floresville, TX, revealed significant deficiencies in their quality system. The firm was cited for individuals conducting quality audits having direct responsibility for the areas being audited, contrary to their own procedures. Additionally, the inspection found a complete lack of documented personnel training records for various critical quality system functions.