483
Excellence Medical Supplies Co., Ltd.FDA 483 - Excellence Medical Supplies Co., Ltd. - July 12, 2019
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Record Details
An FDA inspection of Jiangsu Excellence Medical Supplies Co., Ltd, a combination product and device manufacturer, revealed significant deficiencies. Observations included inadequate stability programs, insufficient laboratory controls for product testing, pest infestation in the warehouse, and failure to properly qualify component suppliers. These issues indicate a lack of robust quality control and manufacturing practices.
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ID · 81fa8258-c1af-4a6a-a29c-33c27c66c69d