# FDA 483 - Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil - September 16, 2022

Source: https://www.keypedia.com/records/483/delta-kozmetik-sanayi-ve-ticaret-selim-yesil/41edf4e7-bfaf-41d8-8503-132d45f2a3ac

> FDA 483 for Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil on September 16, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil
- Inspection Date: 2022-09-16
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Delta Kozmetik Sanayi Ve Ticaret-Selim Yere, an OTC drug manufacturer in Istanbul, Turkey, was cited for significant deficiencies in its quality systems. The inspection revealed a lack of validated manufacturing processes, an inadequate stability program, failures in supplier qualification, and insufficient process controls for manufacturing equipment. These issues indicate a systemic failure to ensure drug product quality and compliance with cGMP regulations.

## Related Documents

- [WARNING_LETTER - 2021-07-20](https://www.keypedia.com/records/warning_letter/delta-kozmetik-sanayi-ve-ticaret-selim-yesil/577eb6e8-0207-476b-9ff9-c7d0323a64b3)
- [WARNING_LETTER - 2022-09-16](https://www.keypedia.com/records/warning_letter/delta-kozmetik-sanayi-ve-ticaret-selim-yesil/2bd5950c-bfe9-44c2-a8fc-61e72ecc87de)

## Related Officers

- [Consumer Safety Officer ](https://www.keypedia.com/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)

Company: https://www.keypedia.com/companies/delta-kozmetik-sanayi-ve-ticaret-selim-yesil/9c26e031-8a47-4446-bd9b-e22d4ba40150

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1