483
Medimaging Integrated Solution, Inc.FDA 483 - Medimaging Integrated Solution, Inc. - July 05, 2018
Record Details
Medimaging Integrated Solution, Inc. in Hsinchu, Taiwan, was inspected by the FDA from April to July 2018, resulting in a Form 483. The inspection revealed significant quality system deficiencies, including a lack of validation for manufacturing processes, inadequate nonconformance data analysis, unqualified suppliers, and insufficient production records for subassemblies. These issues indicate a need for improved quality control and documentation practices.
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ID · 7db8f963-036c-4614-9e7e-112793f25823