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483
•DFB Technologies, Ltd•September 22, 2020

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

Record Details

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.

Company
DFB Technologies, Ltd
Inspection date
September 22, 2020
Product type
device
Office
Dallas District Office
Person
  • Jennifer Cunningham
View Company Profile

ID · 6b8491b9-3f1e-4666-a409-bc018d676eb2

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