Bedfont Scientific, Ltd.October 31, 2019

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

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Record Details

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.

Company: Bedfont Scientific, Ltd.
Inspection Date: October 31, 2019
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Karen M. Rodriguez (investigator)

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