483
SMC Ltd.FDA 483 - SMC Ltd. - February 08, 2019
Record Details
SMC Ltd. in Santa Rosa, CA, received a Form FDA 483 with two observations. The inspection revealed inadequate validation of manufacturing processes for subassemblies and deficiencies in the firm's corrective and preventive action (CAPA) procedures, specifically regarding verification of effectiveness. These issues indicate potential weaknesses in the firm's quality system for medical device manufacturing.
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ID · 7f21ea2e-78f4-4bb7-b5e0-1d1ece0d3089
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