FDA 483 - Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S. - December 12, 2024

Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S. in Esenyurt, Istanbul, Turkey, was cited with three observations during an FDA inspection. The firm's quality system was found deficient, particularly concerning inadequate procedures for corrective and preventive actions, customer complaint handling, and device history records. These issues led to a recall of ultrasound gel due to sterility failures and processing deviations.