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

An FDA inspection conducted from October 28-31, 2019, at a firm in Maidstone, Kent, United Kingdom, manufacturing carbon monoxide gas analyzers, revealed significant violations of the Quality System (QS) regulation (21 CFR Part 820). The devices were deemed adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act. The firm's response dated November 20, 2019, was found inadequate, lacking sufficient documentation and timelines for proposed corrective actions. Key violations include: 1) Failure to establish and maintain procedures for device design validation (21 CFR 820.30(g)), with issues like validation on non-initial production units and inadequate software change documentation. 2) Failure to establish and maintain corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)), evidenced by inadequate quality data analysis, closed CAPAs without effectiveness verification, and unaddressed supplier issues. 3) Failure to control non-conforming product (21 CFR 820.90(a)), as products failing tests were released without proper review. 4) Failure to ensure inspection, measuring, and test equipment suitability (21 CFR 820.72(a)), including lack of calibration procedures for flow meters and no assessment of product impact from out-of-calibration equipment. 5) Failure to establish and conduct quality audits (21 CFR 820.22), with numerous quality system areas not audited in 2017 and 2018. The FDA requires a written response within fifteen business days detailing specific corrections, preventive actions, documentation, and a timetable. Failure to comply could impact federal contracts, Class III device approvals, and the issuance of Certificates to Foreign Governments. The letter stresses that these violations may indicate systemic quality management problems requiring thorough investigation.