Sonesta Medical AB

Warning LetterClosed

Pelin Sari Chief Executive Officer Sonesta Medical AB Industrivagen 7 171 48 Solna Sweden (b)(6)@sonestamedical.seFEI 3010496070Issued Sep 22, 2023Center for Devices and Radiological Health

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Violations6

Issue DateSep 22, 2023

Product TypeMedical Devices

StatusClosed

Closeout LetterFeb 28, 2024

Letter Details

Firm: Sonesta Medical AB
Location: Pelin Sari Chief Executive Officer Sonesta Medical AB Industrivagen 7 171 48 Solna Sweden (b)(6)@sonestamedical.se
FEI Number: 3010496070
Country: Sweden
Issue Date: September 22, 2023
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Closed
Closeout Letter: February 28, 2024

Summary

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.

Sonesta Medical AB FDA Warning Letter, September 22, 2023