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

Source: https://www.globalkeysolutions.net/records/483/dfb-technologies-ltd/6b8491b9-3f1e-4666-a409-bc018d676eb2

> FDA 483 for DFB Technologies, Ltd on September 22, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DFB Technologies, Ltd
- Inspection Date: 2020-09-22
- Product Type: device
- Office Name: Dallas District Office
- Summary: 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.

## Related Officers

- [Jennifer Cunningham](https://www.globalkeysolutions.net/people/jennifer-cunningham/5c332d60-b1e8-444f-8994-68cb1586c7eb)

Company: https://www.globalkeysolutions.net/companies/dfb-technologies-ltd/cf2a5c97-a5a4-42c8-9834-42940a1461de

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9