FDA 483 - Medicol USA Inc. - September 12, 2019

An FDA inspection of Medicol USA Incorporated, a medical device manufacturer located in Los Gatos, CA, was conducted from September 10-12, 2019. The inspection resulted in a Form FDA-483, citing six significant observations related to the company's quality system.

The main issues identified were a fundamental lack of established procedures and implementation for critical quality management elements. Specifically, the firm did not have a written quality policy, which is a foundational requirement. Furthermore, Medicol USA Incorporated failed to establish written procedures for corrective and preventive actions (CAPA) and for controlling non-conforming products, both essential for addressing and preventing quality deficiencies. The inspection also revealed that quality audits, crucial for assessing system effectiveness, had not been performed. Finally, the company lacked established procedures for management reviews and had no documented evidence, such as agendas or signature logs, that management reviews were conducted to ensure the ongoing suitability and effectiveness of their quality system.

These observations indicate a broad non-compliance with the regulatory framework for medical device quality systems. Medicol USA Incorporated is required to take prompt and comprehensive corrective actions to address these deficiencies, establishing and maintaining a robust quality system to meet regulatory requirements and ensure product quality.