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# QS Violations at Bedfont Scientific
- URL: https://www.fdaweb.com/qs-violations-at-bedfont-scientific/
- Published: 2020-05-05T12:00:00.000Z
- Updated: 2026-09-14T16:13:48.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146719

A 10/28-10/31/19 FDA inspection at Bedfont Scientific, Kent, UK, found Quality System Regulation violations in the firm’s manufacturing of carbon monoxide gas analyzers. A just-released 2/12 [Warning Letter ](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bedfont-scientific-ltd-604311-02122020?ref=fdaweb.com)lists the specific violations as: 

- failing to establish and maintain procedures for validating the device design;
- failing to establish and maintain procedures for implementing corrective and preventive action;
- failing to establish and maintain procedures to control product that does not conform to specified requirements;
- failing to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results; and
- failing to establish procedures for quality audits and to conduct such audits to assure that the quality system complies with the established quality system requirements and to determine the effectiveness of the quality system.

The letter says the adequacy of the firm’s responses to the inspection observations could not be determined. Bedfont was told to respond with a list of specific steps taken to correct the violations and prevent their recurrence, with documentation of each step and a schedule for completing them.