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

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.