# FDA 483 - Bedfont Scientific, Ltd. - October 31, 2019

Source: https://www.globalkeysolutions.net/records/483/bedfont-scientific-ltd/00cd71fa-7ce8-4958-a842-03c06e629f90

> FDA 483 for Bedfont Scientific, Ltd. on October 31, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bedfont Scientific, Ltd.
- Inspection Date: 2019-10-31
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Bedfont Scientific, Ltd. in Maidstone, United Kingdom, revealed significant deficiencies in their quality management system. The firm failed to adequately establish or implement procedures for corrective and preventive actions, design controls, and equipment calibration. Additionally, issues were noted with the control of non-conforming products and the implementation of quality audit procedures.

## Related Documents

- [WARNING_LETTER - 2019-10-31](https://www.globalkeysolutions.net/records/warning_letter/bedfont-scientific-ltd/3eac080e-34a4-497e-82f7-fcad568e6b8a)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/karen-m-rodriguez/fcef1f49-583d-45ab-80e2-4c34793fd722)

Company: https://www.globalkeysolutions.net/companies/bedfont-scientific-ltd/253e89ca-00cd-40c6-8e08-128880373668

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