# FDA 483 - Duckworth & Kent, Ltd. - May 17, 2018

Source: https://www.globalkeysolutions.net/records/483/duckworth-kent-ltd/1c3b84c2-d317-48a4-adce-9f56c02c652b

> FDA 483 for Duckworth & Kent, Ltd. on May 17, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Duckworth & Kent, Ltd.
- Inspection Date: 2018-05-17
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Buckworth & Kent, Ltd., a medical device manufacturer, identified four significant observations related to their quality system. Deficiencies included inadequate medical device reporting procedures, insufficient process validation, poorly documented corrective and preventive actions, and a lack of established environmental control procedures. These issues indicate a need for comprehensive improvements in their quality management system.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.globalkeysolutions.net/companies/duckworth-kent-ltd/7f3986ec-87a3-4841-bd67-2029611eea23

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd