FDA 483 - C&T Dream Co., Ltd. - November 10, 2023
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C&T Dream Co., Ltd. in Cheonan, Korea, received a Form 483 with nine observations following an inspection of its pharmaceutical manufacturing facility. The inspection revealed significant deficiencies across multiple areas, including inadequate laboratory records, unvalidated manufacturing processes, lack of stability studies, and poor equipment maintenance. These issues indicate a broad failure to adhere to good manufacturing practices for their OTC drug product, "Walgreens, Dry Skin Healing Ointment."
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