FDA 483 - Meddev Corp - February 28, 2022

MedDev Corporation, a medical device manufacturer in Sunnyvale, CA, was issued a Form FDA 483 with five observations following an inspection. The inspection revealed significant deficiencies across its quality system, including inadequate documentation for corrective and preventive actions, a lack of regular management reviews and internal audits, and poorly maintained complaint files. Additionally, the firm failed to adequately document personnel training, indicating systemic issues in maintaining an effective quality system.