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Sonesta Medical AB, a Swedish manufacturer of radiographic and cystometric tables, was found to have adulterated medical devices that failed to comply with Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Part 820. The company's purchasing controls procedure did not adequately define the frequency, type, and extent of oversight required for suppliers, contractors, and consultants, and the firm had failed to evaluate its contract repair/servicer and quality assurance consultant. These quality system deficiencies were identified during an FDA inspection conducted June 5-7, 2023, with the company submitting responses in June, August, and September 2023 that were found insufficient to address the violations.