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

Source: https://www.keypedia.com/records/483/turkuaz-saglik-hizmetleri-medikal-temizlik-kim-ur-san-ve-tic-as/46bab0f9-757f-46ca-a971-93a9874be84d

> FDA 483 for Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S. on December 12, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.
- Inspection Date: 2024-12-12
- Product Type: device
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Officers

- [Dawn M. Braswell](https://www.keypedia.com/people/dawn-m-braswell/6a66fdbb-fff8-4b4b-9f06-320464957b87)

Company: https://www.keypedia.com/companies/turkuaz-saglik-hizmetleri-medikal-temizlik-kim-ur-san-ve-tic-as/bb0b1c58-dd47-4bb4-b298-0f25cd05706f

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8