483
Diora Kimya Sanayi ve Ticaret Limited SirketiDiora Kimya Sanayi ve Ticaret Limited Sirketi – FDA 483, May 31, 2024
Record Details
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.
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ID · 499c85d0-c7e6-497e-b18a-18ac983e71d4
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