483
DreamCon Co. Ltd.FDA 483 - DreamCon Co. Ltd. - May 08, 2023
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Record Details
DreamCon Co. Ltd., a manufacturer of Daily Wear Soft Contact Lenses, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included a lack of validation for the water purification process and inadequate procedures for acceptance activities. Additionally, the firm failed to adequately investigate product complaints or evaluate them for MDR reportability.
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ID · e1fbb072-0f54-4479-8cfd-01d928eb0228