FDA 483 - Sharps Compliance, Inc. - January 31, 2023

Sharps Compliance, Inc. in Houston, TX, a medical device manufacturer, received a Form FDA-483 with nine observations following an inspection. The findings highlight significant deficiencies in the firm's quality system, including inadequate documentation for complaint investigations, CAPA activities, and nonconforming product control. Additionally, issues were noted with procedures for labeling, acceptance activities, sampling methods, device history records, and design changes.