483
Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.FDA 483 - Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S. - December 12, 2024
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Record Details
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.
- Inspection Date
- December 12, 2024
- Product Type
- Device
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ID · 46bab0f9-757f-46ca-a971-93a9874be84d