FDA 483 - DFB Technologies, Ltd - September 22, 2020

DFB Technology LTD, a device manufacturer in Fort Worth, TX, received two observations during an FDA inspection. The firm failed to implement its procedures for corrective and preventive actions (CAPA), with several CAPAs remaining open past their target dates. Additionally, the firm could not provide documentation of any management review meetings conducted since 2017, indicating a lack of adherence to established quality system processes.