# FDA 483 - Diora Kimya Sanayi ve Ticaret Limited Sirketi - May 31, 2024

Source: https://www.globalkeysolutions.net/records/483/diora-kimya-sanayi-ve-ticaret-limited-sirketi/499c85d0-c7e6-497e-b18a-18ac983e71d4

> FDA 483 for Diora Kimya Sanayi ve Ticaret Limited Sirketi on May 31, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Diora Kimya Sanayi ve Ticaret Limited Sirketi
- Inspection Date: 2024-05-31
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Diora Kimya Sanayi ve Ticaret Limited Sirketi, a drug manufacturer in Gaziantep, Turkey, was inspected by the FDA from May 27-31, 2024. The inspection revealed significant deficiencies across quality control, laboratory operations, production, facilities, equipment, and packaging/labeling systems. These issues indicate a lack of adherence to current good manufacturing practices, potentially impacting drug product identity, strength, quality, and purity.

## Related Documents

- [WARNING_LETTER - 2024-05-31](https://www.globalkeysolutions.net/records/warning_letter/diora-kimya-sanayi-ve-ticaret-limited-sirketi/8e2fcb1c-151e-45c7-939f-0cba4edc9f04)

## Related Officers

- [Mindy M. Chou](https://www.globalkeysolutions.net/people/mindy-m-chou/3d0e74bf-ad6b-48b5-8b72-cbb29e9c9ce5)

Company: https://www.globalkeysolutions.net/companies/diora-kimya-sanayi-ve-ticaret-limited-sirketi/0e484d40-8ee0-4372-a04a-c6eed2441b79

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