FDA 483 - DPT Laboratories Ltd

During an inspection from April 3-6, 2023, DPT Laboratories LTD, a device manufacturer in San Antonio, TX, was cited for deficiencies in its corrective and preventive action (CAPA) processes. The firm failed to verify or validate CAPAs to ensure their effectiveness and prevent adverse effects on finished devices. Specifically, three CAPAs from 2016-2018 lacked proper effectiveness checks.