SMC Ltd.February 8, 2019

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.

Company: SMC Ltd.
Inspection Date: February 8, 2019
Product Type: Device
Office: Division of Human and Animal Food Operations - West V
Person: Quynh Strandberg (Regulatory Review Officer)

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