FDA 483 - Somnomed Inc - May 23, 2025
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Somnomed Inc, a medical device manufacturer in Plano, TX, received a Form FDA 483 with five observations following an inspection. The firm was cited for deficiencies in its quality system, including inadequate procedures for complaint handling, acceptance activities, software validation, purchasing controls, and rework of nonconforming products. These issues indicate a lack of established and followed procedures across several critical areas of device manufacturing and quality assurance.
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